Using the FDA Maude Report search tool there are absolutely no Reports showing for all of 2012. It can't be possible there wasn't 1 adverse event, surgical accident, or injured patient that was reportable.....unless nobody really IS getting that procedure now. Why aren't there any reports showing??
Ahhh there we go. They're finally showing now. Poor guy had a nuvasive plate break in his neck 20 weeks after surgery. Another hospital complaining they can't sterilize the nuvasive surgical tool. One surgeon broke two Coroent XL's trying to insert them...poor patient now has irretrievable plastic chunks inside his spine.... Thanks FDA.
Heard of another Helix coil popping out of plate during surgery.. Maybe not significant but the surgeon is probabaly done with that product.
Wouldn't want to be this patient: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2755748 Back into surgery and the nuvasive implant yanked out and replaced with nothing....ouch.
Or this poor guy: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2748686 Bet that poor chap got some dire nerve damage when that tool snapped inside him.
The latest Maude Report from the FDA says Nuvasive has added a new notice to the plastic spacers (Coroent XL) they are inserting into people without using Fixation (rods/screws/plates) to hold them together: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2939263 """""""""""""Labeling review notes the following: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " "these devices can break when subjected to the increased load associated with delayed union or non-union. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " failure of the patient to comply with post-operative care and sustaining an impact from a fall, likely caused or contributed to the spinous process breakage and the need for revision surgery. """"""""""""""""""" Nuvasive just admitted their plastic spine spacer is not capable of load bearing.....they should have been using FIXATION and securing peoples vertebrae together. Shame on the FDA for not forcing Nuvasive to use Fixation with the Coroent XL plastic spine spacer....it AINT an artificial disk....should have never been used without some means to "fixate" the 2 vertebrae together.
Man, it's been a while since you've posted your nonsense. I've kind of missed it. I don't sell NuVasive, I sell against them. But you've gotta get this into your thick useless skull. NuVasive DOES NOT put in implants. They SELL them. Doctors PUT IN implants. If you have a problem with an implant being used incorrectly, it's because it was PUT IN incorrectly or "off label." But please.... Keep posting because for some odd reason, I enjoy your nonsense.
Nuvasive has been advertising as well as instructing surgeons to NOT use "fixation" with the plastic spine spacers with their 'novel' surgical approach. Now the labeling on their product states the PEEK plastic Coreont XL spine spacer is NOT capable of load bearing. As Vice President Biden said once, "This is F@ckin big!" They shoulda used Fixation in all the patients that got Coroent XL spine spacers. Cadavers.....errr evidence is piling up. Both in the US and abroad.
https://www.justice.gov/opa/pr/medical-device-manufacturer-nuvasive-inc-pay-135-million-settle-false-claims-act-allegations
