There are many great magicians and illusionist. The most famous for our entitlement generation was a Hungarian named Harry Houdini, then there was Robert, his brother, David Blaine, PC Sorcar, Doug Henning, one of TSB's favorites right up there with Penn and Teller, Criss Angel, Harry Blackstone, Jr., David Copperfield and the obvious Harry Potter, the most talented of them all. Hey, was he real? Yet, the more TSB evaluates the spine industry, the real winner must be SpineArt. Why?
For starters, have you ever looked at their website, or is it websites? Is the company SpineArt and why does it default the viewer to K-Wireless? And who is K-Wireless? Since SpineArt is covert in how they present themselves surrounded by mystique and veiled in secrecy, is this really a plot to overthrow the spine world? Where the hell is Etan Hunt when you need him? Last time TSB saw him, he was scaling one of the tallest buildings in the world. Can you hear the music in the background, actually there's an idea. If it wasn't an infringement, SpineArt should have the Mission Impossible Theme Song playing in the background on their website. Oh if Jim Phelps was alive. By the way youngsters, he was the real Ethan Hunt. But back to the chase. Can you hear it fellow Spineophile. Dat, Dat, Dat,......Dat......Dat, Dat.........Dat, Dat, Da..........Da Ra Ra, Da, Ra, Ra, Da, Ra, Ra.......Da, Ra. Come on Spineart its been years since you have been flying the flag of a neutral country, the Butterfly, oops TSB means Switzerland. Though, it does look cute on your implants. So TSB must quote Meatloaf, "what's it going to be boys?"
Your implants look pretty, but what implant doesn't look pretty when they are presented on the web? A cannulated pedicle screw, an option for a micro open (what does that mean Mr. Marketeer at SA) is it open, or is it micro opened, a percutaneous approach and some, butterflies are free, inter-body devices. As Peggy Lee sang, "Is that all there is?" Oh, TSB forgot, based on the latest commentary, you are launching sterile implants, as Borat would say, "that's a nice," but that isn't innovation, now is it? You haven't even entered any of your products into the Spine Technology Awards, which speaks volumes about your products. Your testimonials come from Florida, Missouri, and France, but so what? Based on what anyone can discern by viewing a takeoff on the Rubik''s Cube, you must have some type of disc that comes out of Switzerland, and some bungee cord type of products that must be used for interspinous process cases. So what is it SA? Are you going to be a player of are you really an illusionist looking for some sucker who is interested in buying your IP and current portfolio. TSB must admits Harry Potter would be impressed with the magic that this website creates. It's precision is as beautiful as Roger Federer's backhand.
How about entering the STA in the category of best sterile packaging?
ReplyDeleteGood idea. After all, according to their own people that is their biggest innovation.
ReplyDeleteAnother pedicle screw, more cages, and another perc system, je ne said quoi, stay in Europe they need the help. PS Send chocolate and pate, sterile packaging is innovation, where have you been living in a cave?
ReplyDeleteClearly Mr SpineArt has misspoken. If he truly believes that SpineArt innovated sterile packaging or that sterile packaging truly is his company's biggest innovation, then he shouldn't be working for such a lackluster company or even in the spinal implant industry.
ReplyDeleteNext post.... Orthofix settles whistleblower suit.
ReplyDeleteNot the kind of settlement where they deny wrong doing either. They plead guilty to obstruction of audit. They got busted for waiving co-pays, inducement, forging documents and more, all known to the company.
Deletehttp://www.justice.gov/opa/pr/2012/June/12-civ-724.html
Yep, OFIX definitely does not have the cleanest image in the industry. Now...back to this post and Spine Art's game-changing competition-killing innovation of sterile packaging and other company innovations that will put MDT out of business within the year.
DeleteI agree with MSM. SA has an interesting website, but what are the nuts and bolts of this company? Why are they relevant? What sets them apart? Sterile packaging is not an innovation. You really can't hang your hat on that, now can you?
ReplyDeleteYou all mock sterile implants yet all of your companies are moving that direction. Depuy is trying to replace its reps with vending machines! SpineArt opened in 2005 and are on pace to do 35,000 procedures world wide in 2012. Obviously they are doing something right.
ReplyDeleteSpineArt has the number 1 cervical disc in Europe - must be innovative. They just launched the first K-Wireless MIS system which all the big companies will copy. They have 5 devices currently in trials overseas that are entirely new concepts and materials.
This company is doing everything right. Their chief engineer graduated MIT when He was 16. They are the only company using McLaren's supercomputer to do finite element analysis on their future products. Their head of manufacturing was at Rolex his entire career.
In this market maybe sterile implants is innovative. Cheaper shipping costs, less trays to clean, less liability on the hospitals, UDI markings on all implants. Lower infection risks, the hospitals embrace this concept. Hospitals that will not allow new vendors will allow SpineArt in because of the benefits of sterile implants.
One last question. If any of you were having spine surgery would you choose brand new Swiss Made implants of the dirty nasty stuff you keep in your car and sterilize over and over again? I promise you the public will choose SpineArt every time.
Are you the Marketing Director? If so, just fire yourself because your ra-ra cheers are not what this blog is about. Who cares about your Chief Engineer or Head of Manufacturing? The question was about products and if SA is a player, which based on your response proves no way!
Delete"just fire yourself..." Now that's funny.
Delete8:01 1) Last time I checked many companies package sterile implants in fact many of the major Spine companies package PEEK sterile. I would hardly call your sterile implants innovative or unique. What is unique to Spineart is you offer a limited selection of said implants such as PLIF and TLIF where you have two lengths and go up in height by increments of 2mms versus the competition which has three lengths and goes up in height by 1mm increments to match the patients anatomy.
Delete2) Number one cervical disc in Europe, who cares. In case you haven't noticed cervical discs haven't taken over the market in the US because they have not proven to be superior or cost effective to fusions. I know there are some company sponsored studies that suggest they are superior and cost effective but hardly level one data. Finally if your cervical disc is so awesome why did the Art of Spine pull out of their cervical disc IDE study? Oh right, so they can save money and 510k it in a decade. Yes your going to be a real threat to the spine market selling a product that won't be approved any time soon in a market segment of spine in the US, Cervical Arthroplasty. We are all shaking in fear of this product.
3) Five new Devices that are new concepts and new materials. That is great dipshit except that even if true means each device would require an IDE study to be approved in the US market for use, which would require more money than your annual sales for each IDE study with no guarantee of approval. Like your cervical disc, Spineart management/ownership won't foot the bill for that.
4) Maybe your MIT engineer that graduated when he was 16 and the Rolex engineer should stick to watches. If they are counting on your dumbass to build a business they are doomed as you have no clue about the market. Let me guess your some surgeons brother-in-law or girlfriend or both and this is your first foray into spine. Let me give you some advice, get a clue. I have never seen a competitive Spineart rep in my territory and you and them are the very least of my concerns. I will be out of this business before Spineart is relevant in the US.
Let's please change the discussion to something presently relevant to the industry. Spineart, good grief they have something like 10-15 million in US sales. Please my fucking distributorship does almost as much and is better run.
Oh lastly your K-Wireless MIS system isn't innovative either. Many companies have similar systems such as Pioneer Surgical. It is neither innovative or unique. It equally sucks as well.
DeleteThis comment has been removed by a blog administrator.
Delete11:10 First you need to get all the instruments and implants needed to address surgeon and patient needs. Then you need to get a clue about the companies you represent and the spine market you supposedly know so well. Finally you need to realize that no one in the US gives a rats ass about Europe's innovation, companies or products. For all the innovation that happens in Europe their patient population is essentially lab rats for industry. European surgeons put in a bunch of old, tired has been crap or new stuff with no efficacy to support it use no self-respecting US surgeon outside of a POD would use or rep would carry. Across the pond where the money is competition is a little tougher. The difference is like the difference between Major league baseball and whatever you call it or Professional Football. And I am not talking about soccer dork. I don't jerk off to the Pope, he isn't relevant over here either to anyone that isn't Catholic and that ought to give you a small clue on where I am located. Anytime you and your French bosses want some all you have to do is hire some reps in all States. Which three states does Spineart have representation?
DeleteCheck your history. Everything we use in the U.S was first used in Europe and much was developed in France.
DeleteI have some French rifles for sale, never been fired and only dropped once. Stick to wine bozo.
Delete11:10 Censorship does exists when you're crude, regardless what Fat Bastard thinks or says.................MSM
DeleteI can't believe you removed that comment Adolf. That was self serving because you have an agenda.
DeleteBut aren't you being Assad-like by deleting comments that really aren't offensive to anyone who doesn't have super-humanly thin skin? Or is it that you don't know who Assad is and thought I was calling you an ass in Arabic? Apologies if that's the case. I do not think you are an ass per se.
DeleteThere is so much corruption in the industry. MSM is telling the truth on a lot of the industry but he is also bashing other companies that may not be corrupt such as Paradigm.
DeleteThe industry is full of weasels. Is MSM one? You tell me. I honestly don't know yet. I would like to know who he works for. I'd love to have a chat with him and his boss. I appreciate the fact that he's exposing some of the worst players in the industry but he needs to call them what they are, CRIMINALS!
Let's face it, the industry is full of snakes and they own the FDA and the FTC.
Fat Bastard tells the truth.
Alll the legacy vendors bash any new company in the industry. If all these companies are doing everything wrong why are you all loosing market share? I would have an open mind because the company you crap on may be your future employer. We have seen more big companies fail in the last 10 years and smaller companies come out of nowhere.
DeleteDepuy had internal consultants that recently determined that all spine implants must go sterile. This is why I am competing with a vending machine to keep my job. Whether it is innovative or not our industry is moving this direction and they are teaching us to sell the benefits to our customers.
ReplyDeleteNo one is mocking sterile implants. Just mocking you when you say that sterile implants are Spineart's biggest innovation. As for the list of reasons why SA is supercool, thanks for attempting to answer MSM's question.
ReplyDeleteA question for you; why is an implant that has been sterilized multiple times less sterile than your implants?
What are your 5 devices currently in trials overseas?
I wouldn't want re-sterilized implants put in my back.
DeleteSterile processing doesn't do much in terms of decontamination beside put them through the washer.
Items go in and out of the patient whether we like to believe it or not, a longer rod for distraction that doesn't get implanted, for example, might get placed back in the implant set, that contaminates the whole set when they get re-sterizled if it doesn't get taken out and properly decontaminated.
If a hospital removes the liability of sterilizing spine implants their insurance goes down 100k/year. I have always wondered why spine delivers non sterile implants when joints have been sterile for a long time. No one would implant a hip that was sterilized over and over. I agree our industry will be forced to move this direction.
ReplyDeleteFDA has been barking up this tree for a while now: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm234102.htm
DeleteThe FDA could write that letter to every spine company in the industry. They are all stored in filthy warehouses.
DeleteWhy is an implant that is sterilized multiple times less sterile than a sterile packaged implant?
ReplyDeleteTotally agree - sterile is sterile, however the fact is that through sterile packing there is a lot more control over the cleaning process. Regardless both have non-sterile instruments that have to go through the repeat process
DeleteAs to hips, knees etc being ahead of the game, they have bearing surfaces - like TDRs you would damage the surface finish through constant cleaning and cooking......
Lukianov needs no sterile packaging when he tells Congress where to stick the Medical Device Tax! Not a NuVasive devotee or user, but way to go!
ReplyDeleteJust went to SA website... creepy.. One headline reads Dr. so-and-so "based in South California just completed the world first 4 levels MIS percutaneous construct without K-wire using..". (seriously!) Guess they didn't hire the 16-year-old MIT-trained English major. Also, didn't know Guinness was keeping track of World's Firsts in their sham surgeries category.
ReplyDeleteI guess after a few sterilization cycles the "bugs" develop an immunity to high temps.
ReplyDeleteHow is removing the K-Wire a sham. This makes the procedure safer, faster and cheaper. SpineArt uses the same non-cannulated screw they use in open procedures for MIS. Your companies engineers have not been able to figure it out or maybe the wanted cannulated screws to create more royalties?
ReplyDeleteAs far as re-sterilizing, it adds unnecessary risk and liability to the hospital. They can save 100k/yr on their liability insurance not sterilizing spine implants. Take a look at what the joint companies are doing with less trays....they hospitals love it! if a car sat at a dealer for 2 years can they still sell it as new?
Take your screws out and wipe your tray with alcohol and see what happens. Everything that comes off is going into patients. I did a demo the other day and almost watched the surgeons head explode. open your mind and think about what's best for the patient.
I don't think 100k/yr is a huge savings, but I do like the idea of sterilized screws.
DeleteI work for the hospital, and I would work towards buying your instrument sets if the usage is justified so that all we would have to worry about is stocking the screws.
I have never heard of SpineArt, but several of the bigger vendors have mentioned to me that their companies are headed in the sterile direction. I'm on board.
You know what? Has anyone died from non-sterile pedicle screws? Highly unlikely? How many patients have gone on to infections? In all likelihood an insignificant amount in the statistical world. All SpineArt is doing is feeding the beast, first it was RapeTrax, then it is one rep in the room at a time, then it is we're protecting the patient BS, let's face it, this is another bureaucratic ploy by a small company in an attempt to gain business. If hospitals mandate sterile implants the big boys will crush you in a NY minute. What next, sterile instruments? Considering the SpineArt rep dresses in scrubs and where's those same scrubs in the OR, there goes your sterility issue.
DeleteTSB contain yourself you spelling reminds us of the MIT grad who is brilliant but can't spell or write to save their life.
DeleteBy purchasing the instruments it will put greater onus on the hospital to properly decontaminate the instruments. This involves taking a scrub brush to each one, a process that does not regularly occur with "loaner" instruments/implants.
DeleteOur facility allows multiple reps for cases. And each rep has to check out a fresh set of scrubs for the day. I'm all for having whatever team members present to help the surgeon succeed.
You can still come to the room and help out. But leave the screw ordering to the hospital. Make the process more like ordering tissue.
Please, are you going to go to sterilized trauma screws for Orthopaedics as well. This is subject is so stupid.
DeleteMost hospitals own those trauma sets, they're not rolling around in the back of your Honda Pilot between cases.
DeleteBut I wouldn't be against it.
Hey limp biscuit I don't drive a Honda Pilot. If hospitals mandate sterile products tomorrow or customers start demanding them Depuy, Stryker, Zimmer, Biomet will flip a switch and any perceived competitive advantage will be gone. You do realize the companies mentioned above already package all their total joint and some of their spine stuff sterile.
DeleteYou talking smack reminds me of the joke about the ant and elephant or the rabbit and the bear. The morale of the stories are the ant and rabbit are insignificant except in their minds. Once again I will be impressed when I see a Spineart rep much less see one take some business.
The infection rate for non-instrumented cases is less than 1%. The infection rate for instrumented is 3-12%......no matter what your hospital tells you. Patients die of infections all day everyday. If this can help prevent infections how can we argue against selling sterile implants? Regardless of the company this seems better for the patient.
DeleteLimp biscuit here,
DeleteYou act as if I don't want the companies you mention to go sterile... I do, that is the point I'm trying to make. I never heard of these spine art people.
The hospital infection rate in the US is 1 in 9. Bone infections are very difficult to cure. nearly ALL infections are preventable.
Deletewhats your source that the infection rate is 1 in 9 and what studies do you have that demonstrate sterile PACKAGED implants lower them.
Deletehttp://www.hospitalinfection.org/ This site says one in ten and they got their numbers from the CDC.
DeleteIt's probably higher than 1 in 9 because the worst offending hospitals don't report. A lot of reporting in voluntary.
There is also no way a vendor would study this because no good can come out of it. I have never heard of Spine Art but if they help to shift our industry I applaud them...........I also hate delivering 16 trays for a lateral case!
DeleteEven if the infection rates you state are correct, that says nothing about an improvement on those rates with sterile packaged implants versus steam sterilized implants. And I don't recall EVER hearing about a patient that died from an infection acquired during spine fusion surgery. I'm 15 years in, so I'm thinking that your claim that people die "all day, everyday" may be a bit exaggerated.
DeleteIf you are at a center that does complex cases you will see infection related deaths. Also, hardware related infections can take up to a year to materialize. I don't know either way how used or new implants effect infection rates but down playing the risk is irresponsible. We should be doing everything in our power to avoid putting patients at risk. If proven sterile implants reduce infections rates we need to make the move.
DeleteExaggerated, its down right irresponsible. Now all we need is another bean counter reading this blog and we'll have new legislation.
DeleteTSB believes that Fat Bastard and El are related. Twin Sons from different mothers? One never knows, but something smells fishy
ReplyDeleteGood detective work Columbo.....no one cares.
DeleteMSM who are you really? Why do you fear Fat Bastard?
DeleteFear the Fatman LOL! Let's skewer the pig and have a pig roast
DeleteSo, lets say your idea of sterile implants gets adopted..great, in short while all the companies will offer them.
ReplyDeleteThat leaves you..... Where? With what great products now that everyone is on a level playing field? Thanks for the idea..."Now Bu - Bye!"
Ok, you have to throw away all your current inventory because it cannot be repackaged. How much will that cost? How long will it take you to convert?
DeleteFinally, good! You need to offer sterile implants. It validates everything SpineArt has done and is doing. Imitation is the ultimate form of flattery. Now get to work throwing away millions in trays and inventory and loosing more money this year. It will pay off in the future. Bu - Bye
What does Spine Art do when an implant is opened in the OR and not used? Let's say the doc changed his mind about the size needed and the implant is no longer sterile but was not implanted/explanted either. It did not touch any blood.
DeleteIt can never be repackaged and sold in the U.S per the FDA. It gets sent back to Geneva or used for training.
DeleteSo it can be sent back to SpineArt, repackaged and sold anywhere outside the US (and the reaches of the FDA), which I'm quite sure is done. Hmmmm, resterilized implants at SpineArt!!! You filthy SpineArt pigs!!!! Actually, it's not uncommon for a surgeon to change his mind about a screw or rod size so it's not like this doesn't happen on a somewhat regular basis.
DeleteThey are not repackaged. They are sold at a discount to bankrupt countries just like your nasty implants should be. The difference is at the time they are sold they still have only been sterilized once.
DeleteWell, I like my implants sterilized twice, that way they're twice as clean!!!
DeleteOhhh, so in order to get SpineArt's clean once-sterilized implants you have to live in a rich country? All of your sterilization rants go out the window since you admit you're willing to sell implants that have to be sterilized multiple times in order to be implanted. Chump.
DeleteWHAT?!?!?! After all this spine fart guy says about resterilized implants being dirty, he now admits he's willing to sell implants that have to be resterilized multiple times in order to be implanted (and by his definition "filthy").
DeleteMSM there are people being crude you better censor their comments.
DeleteWhat's crude?
DeleteSterile implants won't gain you access in my area. You have to have a surgeon that wants your product, and even then it's hard.
ReplyDeleteI'd like to see where you got the $100K savings in insurance. Sounds to me like a salesman's tactic to charge a little more and you are using that $100K as justification. I find it hard to believe the liability insurance application asks if spinal implants are steam sterilized or packaged sterile. If that question IS on the application, then the form must be 10,000 pages long considering the number of variables that exist in a hospital and the products it purchases.
When the hospital sterilizes an implant the liability falls on them if there is every an issue. The insurance company calculates that into their premium. If they do not sterile implants they are not charged for the additional liability. Did you seriously need that to be explained to you?
DeleteYes because even if they use spine art exclusively, they will still be sterilizing other implants in house. Tell me how an insurance company is going to adjust their premium based on one vendor in one specialty providing their product sterile. No insurance company is looking at that level of detail to determine the premium it charges. Most of us in the industry have never seen a Spine Art implant. I can assure you insurance actuaries have no idea who your company is either
Deleteit seams that the only implants being sterilized are Spine and trauma. Being that the hospital owns the trauma sets this may be a valid point they could make to their insurers. Although a long shot it is good business to look into it as any savings is a benefit.
DeleteCranial plates, anuerysm clips, ortho implants (trauma and other), maxillofacial implants, dental implants. All resterilized after every case. I'm sure there are others.
DeleteDental are no longer re-sterilized. The companies replace open unused implants. Anuerysm clips are pre-packed and trauma sets are owned by the hospital. The entire industry has been moving to pre-packed sterile since the early nineties. Spine and Trauma are the last hold outs for some reason.
DeleteRight now the best ADR is the NeoDisk and all it is is a chunk of silicone wrapped in a fabric weave and held into place with metal screws. I have an elegant solution for screws and attachment.
ReplyDeleteSpine Art should be called Spin Art.
Why don't you wipe the spunk from your chin before you ever associate the word elegant with yourself Fat Bastard.
DeleteAnon, FB is kicking but and exposing you industry hacks and all you have is some immature schoolyard insult to hurl at this him.
DeleteIn my line of work we protect the oppressed and down trodden from tyrants like the medical industrial complex from creeps like you. We don't fine them. I think you know how we handle punks.
Looks like Fat Bastard has his blog followers flooding spineblogger.
DeleteNobody with real ideas spouts off about them on TSB or anywhere else. And who calls their own ideas "elegant"? You sound like that kid on the playground that nobody liked because he always had to one up everything but never actually did anything.
DeleteAnd who is this "Metal on Metal" groupie of FB that somehow knows he is kicking butt? Kicking butt at what? Designing discs replacements? Sales? Blogging? Fiction? Eating cheeseburgers?
If you click Metal on Metal you will see who he is. I think that members of his profession could clean up the medical industry with the strategic implantation of lead.
DeleteFat Bastard owned you CONservative chicken hawks. The day is coming when the oath takers start going after the domestic corporate terrorists. It won't take long. After a few of them bite the dust the rest will rat out each other and beg for prison.
Can we please discuss something besides Spineart, they are not even relevant. Hell Paradigm Spine has way more in sales and their apparently going out of business per this blog. I mean, we have just given this company and their idiot reps more publicity than they have received since their ill fated decision to enter the US market. I mean Choice Spine has more US sales than these clowns. They could make gold implants, sterilized with pixy dust that gives the implanter a free wish and it wouldn't change the fact that their market share in the US is probably 142 out of 150 companies. They don't even carry a cervical plate in the US. I am more worried about Vertebron or IST than these guys. Yes I know they went out of business and assets were acquired, that is the point.
ReplyDeleteI mean...I mean...Go back to third grade grammar class rookie...
DeleteIf your working for Spineart and calling other people rookies that is rich
DeleteNot working for Spineart, just reading. And you sir, sound like a fucking retard. THAT'S rich.
DeleteOh if Depuy's internal consultants said that Sterile Implants are the waive of the future the one thing you can bank on is they are not. I would take the other side of "Depuy's Internal Consultants" all day and feel like I had a pretty good chance of winning some money if we were betting, which we are.
ReplyDelete"distributions from Spinal USA have been reduced by over 30%, due to pending investigations of Spinal USA and adverse publicity in the Wall Street Journal"
ReplyDeletesource?
DeleteDr. Molleston's bankruptcy pleadings.
DeleteAny thoughts on the "investigations"?
Where is the real MM. This guy is obviously a rep and an idiot. Who would argue against sterile implants?
ReplyDeleteWere not arguing you against sterile implants were laughing about Sterile Implants from Spineart.
ReplyDeleteThis comment has been removed by a blog administrator.
ReplyDeleteOnce again, please refrain from derogatory comments
DeleteSTOP CENSORING, are you controlled by the FCC? If you are that sensitive stop blogging.
DeleteFB go to your own crappy blog spreading your propaganda to your family and friends redneck
DeleteExactly! None of us are saying there is anything wrong with sterile packaged implants. We're simply saying that when you claim that as your claim to fame, you don't have any fame. This guy from SpineArt said that their biggest innovation was that they sterilized their own implants. His words, not mine. First of all, SA did not innovate this method. Further, if that's your biggest innovation then you have no innovation. This company is very obviously trying soooo hard to be relevant and to oversell themselves. Saying that the company owners did not sell because they just did not want to sell the company yet is the same as saying they have only been offered what their company is truly worth, peanuts. I understand the guy trying to defend his company and I'm sure he's wishing he could take back that "biggest innovation" comment. Anyway, I guess he's been beaten up enough.
ReplyDeleteWas the iPhone innovative? Apple didn't invent the cell phone. It is all about the user experience and any improvement in any industry is innovative. Starbucks didn't invent coffee but they improved the experience. You are narrow sighted and need to attend business school. Based on your criteria of innovation 90% of companies should have failed.
ReplyDeleteIf you attended SpineWeek you would understand how big of a global player they are. it's just like all you globus bashers. At the end of the day they took business from every company. Being dissmissive of any company is very short sighted and nieve.
Apple innovated the cell phone industry, the music industry and the computer industry. Spineart hasn't innovated shit. One company is a multi billion dollar company and the other company maybe has 45 million dollars in total sales. Maybe you need to go to business school you retard. Comparing Spineart to Apple, really? Oh I am sure they are big players at SpineWeek, only thing is I have been in Spine for fifteen years and never heard of SpineWeek. Is that like a cross between bike week and gay pride week where all the ankle biters in spine put on there chaps and ride into town with their innovation flying high. I am sure Spineart was the talk of the town. Funny thing is not a surgeon in a five state radius of me attended SpineWeek so who did you convert.
ReplyDelete15 years and you don't know about SpineWeek? Hahahahaha look it up and you will feel like an idiot. hahahahahahahahahahaha...........................hahahahahahahahahahahahahahahaha. "I have been in spine for 15 years and have never heard of SpineWeek" hahahahahahahahahahahahahaha you are a low level hack....hahahahahahahahahaha.
DeleteSpineWeek is held every 4 years bringing 8 of the biggest spine societies together in one place. It is a huge global meeting with top Physicians from all over the world.
DeleteYou should Google things before you comment.
I looked it up. I apologize, I didn't realize you meant The 3rd Spineweek sponsored by the Dutch Spine Society how did I not know about that meeting. I forgot, I was going to attend but had to cancel my trip to stay home and pressure wash my drive way and take my kids to a movie.
ReplyDeleteStop, you keep making yourself look dumber.
ReplyDeleteI've never heard of SpineWeek either.
ReplyDeleteI guess you haven't been beaten up enough, Mr. SA. This is the second time you've compared spineFart to Apple. A "me too" company with weak sales, who sells refurbished implants to poor bankrupt countries, should never be compared to Apple. SpineArt is silly and you have eaten your own words on this blog. Resterilized implants are dirty, you say. Yet you admit you sell implants that have to be resterilized to be implanted. Get off your high horse and realize that your innovation is no innovation. Your company is all puffed up trying to make the sell and to be sold. And all the while, you are the sellout. I have no love for SpineArt. They suck ass, completely.
The guy you refer to as Mr Spineart, isn't at all. He's a rep trying to make a grind selling implants for Spineart. I know who he is and Mr Spineart he is not.
ReplyDeletePlease open that Sterile Packaged retractor system and Kerrisons and pituitaries and and and
ReplyDeleteApple didn't just innovate they revolutionized three huge industries each of which are much bigger than spine. SpineWeak. What a joke. I rarely attend all the bs US meetings much less the 3rd SpineWeak meeting. This is what I referenced earlier, your a master of your universe, which fortunately for the rest of us that live in the real world your not even a nuisance. Go on beating your chest and comparing your company to other great companies out of spine and in spine. After they fire you for poor sales you will be spouting off about another Tier 3 wannabe.
ReplyDeletewhat everyone is missing here with the sterile implants is the FDA. Forget about innovation...
ReplyDeleteThe FDA is cracking down on the tracking of lots/SN #s of implants as a way of trackability for infection, product failure, etc. Currently, the FDA only requires tracking for 14 specific medical devices (tissue excluded). With the issues with hip replacement failures, pacemakers, breast implants etc... this has started to trickle over into spine. I dont know about all of you, but I cant remember the last time i jotted down a lot # for a cervical plate or pedicle screw as it was being implanted. Meanwhile, what happens if a bad batch of pedicle screws go out and the heads pop off...how would we know?
The sterile implants will be each company's way to once again bend over for the FDA and say they now have a safe effective way to track all implants, both tissue and non-tissue. Taking the responsibility away from us more and more...It's not that we are being innovative...we are being forced down this road by the FDA
Are you kidding me? As a circulator in the room we document the lot and serial number of every plate, screw, allograft that goes into the patient's body in their legal chart. We then keep a log of tissue and a log of implants in hard copy. Then we make a copy of your charge sheet and I always make a copy of everyone I sign. All of the good reps I deal with do the same which comes in handy for revisions and/or litigation.
DeleteThe "lot" number for re-sterilized instruments is the load# from the steriziler they were cooked in. If anything happens we can look at that load and verify that a biological spore test has been run on that machine.
Periop 101 man....
The fact that sterilization is even an issue shows just how reckless and sinister the industry is.
DeleteMost American spine surgeons are greedy, stupid and corrupt.
What a great selling point. We sterilize our defective Frankenstien devices before we put them in you. This way you will only die from cobalt poisoning.
DeleteLOL Dr. Buster, Stryker manufactures their spinal implants in France and ships them in lots to the US in "non-sterile" packaging. This way, when the patient dies from either a bone infection or nickel, cobalt, chromium poisoning, there will always be doubt as to the real cause of death. Did the hospital NOT properly follow the instructions on the package protocol? Did the doctor inform the patient of all the metals in the device and prescreen for metal sensitivity? (Did you know that Stryker never follows CT protocol during the trials, yet deceives the surgeons into believing that it had by putting the FDA approved protocol on the packaging? now, this is an illusion that savvy surgeons should investigate - which is to ask their surgeon buddies who participated in the Stryker CT trials whether they prescreened their subjects for metal allergies or sensitivities before enrolling them into themtrial? The real truth is scary - as not one single research subject had been screened for metal allergies or sensitivities in any Stryker CT for metal on metal devices) NONE THE LESS, STERILIZED PACKAGING IS AN FDA REQUIREMENT yet compliance with adequate safety clinical trial protocol for metal devices is a question that Stryker will never have to disclose - even if the research subject dies from metal poisoning. Stryker has the game set up for the surgeon to take the fall, and the surgeon has it set up to get full protection from all of the other surgeon, with am conspiracy of silence. So in the end, does it really matter whether device is steriled or not? Untreated metal poisoning is far more fatal and will probably be the cause of death in the end. The FDA treats the industry like the "client" - and the patient like the " unwashed masses" - powerless to do a thing about the abuse and deception that goes down in the name of a regulated health care industry. The health care fraud in this industry can be sourced directly to the internal affairs of all clinical trials. That is where the FEDs should begin their criminal investigations, looking within.
DeleteThat's some unadulterated bullsh*t you're spewing. What kind of quack doesn't check the patient for metal sensitivities prior to sticking a permanent implant in them? The manufacturer's responsibility is to identify the materials in the labeling. It's the surgeon's job to make sure those materials don't kill their patient.
DeletePeriop 101,
DeleteIf you are recording the lot number as the sterilizer load, then you are not recording the lot number of the implant. That may be helpful if there is a wet load, but useless if there is a recall of a bad lot number.
Reply to 4:47 pm: not one single research subject in the metal on metal CerviCore disc implant w(sponsored by Stryker Spine) was prescreened for metal allergies or sensitivities. Nor was the fact that "nickel" was part of the metal alloy AStM disclosed to the research subjects in the CerviCore clinical study. Additionally, the only place you will find any indication that this study exits is to ckecknthe FDA Black Lock Box for 'trial of device Not approved or cleared by US FDA'. The SS CerviCore metal on metal disc study was registered in this covert database under the code for Delayed Posting. This means that when the SS representative ( Susan Kransey) registered the device there, instead of the mandatory clinical trials.gov, she had to admit that the study was never FULLY approved for any use, what so ever.
DeleteBack up to when the CerviCore devices arrived in the US in "non sterilized" packaging. Then move forward to the FDA inspections of the Mahwah facilities where the CerviCore disc and the surgical instrumentation kits were stored and sterilized ( supposedly) prior to shipping the devices to the FDA approved study sites. Then read the 11/28/2007 enforcement letter to CEO MacMillan and go to the part where the FDA states that ALL OF STRYKER'S Class 3 applications for PMA are suspended due to non compliance with "quality control" regulations. Since the devices were never inspected upon entry and cleared, the quality control issue was incurable, like a court not having subject matter jurisdiction. There is no way to cure a fatal legal defect.
Evidently, there were approximately 48 surgeons who knowingly implanted non sterilized discs with toxic metal components that were never disclosed to the research subjects nor were they pre-screened for metal allergies. Every single surgeon who implanted a CerviCore disc, did it with full knowledge that they may be either infecting or poisoning their subject they lured into the study. Every surgeon KNEW there was nickel in the device. Everything I have stated can be substantiated and documented. The surgeons involved in Stryker Spine CerviCore study conspired with Stryker to intentionally harm the research subjects and then to cover up their criminal bio - medical malfeasance, they refused to report the severe adverse events to the FDA. The entire chain of command was involved in this fast track malicious research abuse and torture by covering up what the surgeons did to these subjects and refusing to remove the disc even with evidence of tumors developing, osteolysis, bone necrosis, vasculitis and subsidence of the device. The surgeons conspired to conceal these adverse events from the FDA on the order of the CEO of Stryker and the surgical team who designed three different prototypes of the disc that was never FULLY approved with an Investigational Device Exemption. All the CerviCore disc had was a conditional approval in 2006, with 45 days from the date of the letter to comply with the terms for full approval for an IDE. If it had the full approval, the CerviCore study would have been listed openly in the database for applicable trials at clinical trials.com. This is not the case! It has been listed in the FDA black box since 12/21/07 under delayed posting as a device never fully approved for any use.
Check out the movie 'Puncture'. This should give you an idea of the power held behind the scenes. Even with sterile implants available, the hospitals won't have them until the government implements them amongst GPO's
ReplyDeleteI guess it is a moot point but I would say infections in hospitals rarely occur from implants and instruments. More often the patients and staff have bacteria on their bodies, the rooms are failed to be clean adequately or a staff member that comes in contact with the patient does not wash or thoroughly was their hands. Whether the implants come sterile or are sterilized in the hospital there is a chance both processes could be compromised and unsterile implants delivered. IF it was me I probably would prefer an implant that has just been sterilized than one that has been in packaging for several years as just as many companies have gotten in trouble over their manufacturing, quality and sterile packaging and the underpaid be on companies assembly lines are in my opinion not a lot better than most hospitals CS. Maybe a little better!
ReplyDeleteWhat companies have had problems with sterile packaging? 99% of everything used in the O.R is pre-packed sterile. You would prefer sutures, skin staplers, drapes, etc. be sterilized by the staff at the hospital?
DeleteSo, as a patient, you would rather receive a sterile packaged implant that has been rolling around in a rep's trunk for months during the hot summer? The same sterile packaged implant that the rep quite possibly dropped on the ground more than once on his way into the hospital for your surgery? Sterile packaged implants are only sterile if the path that they take on their way to the hospital is tightly controlled and standardized every step of the way. Not even the Depuy vending machines can claim this level of control and standardization. The truth is that all of this talk about sterile packaged implants is nothing more than smoke and mirrors created by the manufacturers that we work for (or distribute for) to cut us (the reps) out of the equation. For a vast number of reasons, I can promise you that this initiative will not be successful. Vending machines cannot stock themselves, and they cannot form strong relationships with surgeons.
ReplyDeleteWhy not have the screws shipped and stocked in the same way tissue is?
DeleteThes pretzels are makin me thirsty!
ReplyDeleteAgain Americans not aware of what is outside the US. Ufffffff !!!!
ReplyDeleteLast week I attended a cadaveric workshop in Dubai conducted by spineart to try their products. As a consultant of spine surgery, I found their K-wireless implants to be very convinient compared to other implants using K-wires. Their retractor is good but I will be working on getting an even less bulky retractor to achieve minimally incisional approach.
ReplyDeleteI tried to understand the arguement on this page , but it didnt apeal to me ,so please clarify coz I might be shifting a considerable amout of my work using their products.
Thanks