Tuesday, February 1, 2011
Synthes To Recall N-Hance Rods?
It was reported today that Kurt Birchler has asked the Syntes (love that lisp) Spine Salesforce to send in all of the N-Hance Rods from the field. This was probably a long time coming considering they were rumors on the Street that Synthes was experiencing technical difficulties with the rod. Voluntary or Not, The Arbeitsgemeinschaft Osteosynthesfragen spent $75 million on this acquisition. Would it be safe to assume that this was an investment that has gone belly up? Considering that David (I'm a rocket scientist) Nicholls and Hansjoerg Emch were fired last year for exhibiting incompetence, could Birchler and Michelle be that far behind? TSB wants to know what its readers think?
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ReplyDeleteThis should have happened a long time ago. Nobody in the sales force sold this dog and most are happy to see it go.
ReplyDeleteShe put the lime in the coconut, she drank them both up
ReplyDeleteShe put the lime in the coconut, she called the doctor, woke him up,
And said, "Doctor, ain't there nothin' I can take,
I say, Doctor, to relieve this belly ache?
I say, Doctor, ain't there nothin' I can take,
I say, Doctor, to relieve this belly ache?"
"Now let me get this straight ",
You put the lime in the coconut, you drank them both up?
Long time coming for sure. At the sales meeting when they showed us this rod, we all looked at each other and said "really?"! We are glad this is off our quota lists.
ReplyDeleteBirchler didn't have much to do with the acquisition and while he is a different duck, I think he does a fine job considering the rigid Swiss above him.
It was a bad purchase but I'm proud of the Anspach acquisition, step in the right direction. We need more steps like this to level off and begin moving north again.
Another nail in the coffin of "dynamic fixation." Until someone develops a system that can actually handle the extreme loads placed on these systems, the failures will keep coming. Remember the (fr)Agile rod?
ReplyDeleteGlobus Transition!!!
ReplyDeleteIt's safe to say none of the Synthes reps are crying about N-Hance being recalled. Every company has a mad dog in their kennel, at least Synthes had the balls to shoot theirs before it jumped up and bit them.
ReplyDeleteDyneshit is the future!
ReplyDeleteDo your homework blogger, the FDA ordered all of manufacturers to do a study or no longer sell the product of this nature. It is effecting everyone and your article sounds more like gossip then fact. Read the FDA announcement and it is clear that everyone must do a study or stop selling dynamic. One question, why didn't you just google the subject before launching this? You missed the meat of the topic and that is the FDA action to all companies.
ReplyDeleteSome like someone has their knickers pulled up too tight.
ReplyDeleteIt not surprising at all. N Spine got that system cleared during the golden days when FDA was lenient of "adjunct to fusion" business. FDA is tightening the noose now, so every company is under pressure...Only the fittest (may be richest) would survive.
ReplyDeleteDon't know who said it above, but look up the FDA requirements going forward. All selling a dynamic fusion device received a 522 letter. The letter states that all those who have a dynamic rod cleared for fusion must know prove it is being used for and actually works as a fusion device. Since there are few companies that have that kind of information (though there are a lot of hybrids of fusion and dynamic levels) everyone with a dynamic system are in a bit of a cluster. And, as usual, the FDA said, "you folks gotta do this and that". Yes that's a simplification, but read the letter. What and how companies are supposed to follow the 522 letter is clear as mud. So, it's wait till the FDA makes up their mind or do an IDE. That's a tough proposition since 3rd party won't pay for it even if they did. What payer is going to fit dynamic fusion in the Millman criteria whether it fits or not.
ReplyDeleteDynamic fusion or stabilization works, just not good enough all the time. Too many Drs. jumped on the band wagon, didn't read the directions, thought they had a hammer and everything was a nail. Just doesn't work that way. We all have to remember 50% of all surgeons graduate in the lower half of their class, but the all have the same title, "Doctor".
The company that figures it out, is willing to invest - and invest big to include a plan to address 3rd party resistance, will have a hell of a run.
I did sell the stuff, and a lot of it, for 2 companies (not N-Hance, Dynabolt, or Fragile, thank God), and it was a lot of fun, especially when surgeons used it as indicated and paid enough attention to do it right. Patients were very happy when the stars and moon aligned. Sure was a bad day when they didn't.
6:54
ReplyDeleteThat’s why engineers should design a system easy enough for a monkey use. Saying its surgeon error is a cop-out! What’s the difference between a wrench and a ratchet? Nothing, only one gets the job quicker. Guess which one? Depends on the engineer.
Now go out and sell a dynamic rod off-lable before their shipped overseas.
N = N* fp ne fl fi fc fL
ReplyDeleteThere is no future for this "dynamic stabilizatin" BS.
ReplyDeleteThese devices all got FDA clearance as spinal fusion devices. The FDA is now (after the fact) requiring that they prove that they perform their intended use, ie fusion. If they do the required study and prove they don't get fusions, they'll eventually be removed from the market. If they do the study and prove they get fusion, they're not "dynamic" and will fail in the market. If they don't do the study, they'll likely be removed from the market.
Contrary to prior posters, the company willing to invest in doing this study right is the dumbest!
Next Fad please...
... it's actually a genius move on the FDA to get the regulation of these on the up and up.
ReplyDeleteGotta hand it to the Feds, really clever!
I'm not surprised to see the POS product being jerked off of the market. The whole design was based on a 4mm inner rod sheathed with polymer bushing. It was destined to fail.
ReplyDeleteTo make it worse, the whole team putting together N-Spine was a band of idiots. A cheeseball engineer with no medical device experience that was full of himself doing testing in their cubicle of an office with some homeade contraption, a drug addict schmuck trying to run their wanna-be sales force, and of course the incredibly dynamic Korean personality that brought this cancer to our country.
Almost as bad as buying this product is that Synthes still feels that it is necessary to keep many of these people on the payroll as employees to spread their filth.
The product was withdrawn from market not Recalled. A recall indicates potential safety or efficacy issues. This is not the case with this device. The company responded to the FDA's request for a post market clinical trial by choosing not to invest. All makers of these devices will be subject to the same "decision".
ReplyDeleteThis product has been withdrawn and it is likely others will follow.
5:09, some of what you state is true, but not the part about "if they do the study and get fusion, it's not dynamic" is a total crock. In EVERY other aspect of bone healing devices, all have some method of dynamic compression. NO one would ever put an external fixator on a patient with out dynamic compression; ever heard of a compression plate, a compression hip screw. How do you think those things work? Those of us who were around when CD hit the market learned the stuff was so damn stiff it was practically a non-union machine. And adjacent level degeneration was not only common, it was somewhat expected.
ReplyDeleteGood God, go read something before you make an ass of yourself.
Alphatec is next...
ReplyDeletehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm239848.htm
Sorry 7:04, you're the moron. (And this is not 5:09.) I think everyone knows that 5:09 meant "dynamic" in the sense that it is a stabilizing, but non-fusing, implant that still allows some motion. If surgeons were implanting it with the purpose of getting fusion, they'd also be performing interbody or posterolateral fusions with it. (Or are you going to rip on me for saying "fusion" when they are actually only "grafting" you pinhead.)
ReplyDeleteAnyone heard of Dynamic Cervical Plate? 5:09 or 11:48 curious if your aware of this new technology launched about 10yrs ago.
ReplyDeleteYes 6:18, but keep up with us. They are fusion devices, used with interbody grafts. They aren't intended to have any motion in the long run. Lest you haven't figured it out, the word "dynamic" has more than one meaning in the context of spinal implants. 5:09 was talking about a dynamic stabilization device, not a dynamic fusion device.
ReplyDeleteAnyone know what happened to the sales manager (forget his name, rhymes with SLEAZY)at N-Spine, before Synthes wasted 22mil?
ReplyDeleteInteresting follow up on OTW in response to this post. Here's the kicker, even though the word recall in our industry has potential implications that the FDA would be involved, that was never stated in this post. In addition, did anyone notice a big question mark behind the title of the post? Voluntary or Not "the company withdrew" the product. No matter how you slice it, it was taken off the market, as for Synthes, they sure are thin skinned. Enhance = a waste of money.
ReplyDeleteThis effects maybe 10 people in Synthes. Those 10 are the only ones who give a rat's patoot. I as a rep for Synthes am clad to see it drug behind the shed and put down.
ReplyDeleteThis is the same old same old situation with new "technology". Every doc wants to be first, and everyone wants to make a sale.
ReplyDeleteThe lisp joke is getting old...
ReplyDeleteHey I worked for the old man and he does have that funny lisp. You must be a Syntes dweeb
ReplyDelete