The CerviCore OASYS Midline Occiput Plate is supposed to stabilize the junction between the occipital plate and the vertebrae in the spine and is part of the OASYS Occipito-Cervico-Thoracic System intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction in the body. Manufactured by Howmedica, doing business as Stryker Spine, the device was only approved for use by the FDA in 2010. But our Houston metallosis injury lawyers point out that less than three years later, the device had already been recalled.
The final FDA recall of the Stryker device was listed as Class I, the most serous type of recall, where serious injury or death might be a real possibility from failure of the device. Unfortunately, by that time, it had already been implanted in thousands of patients and had been tested on hundreds of others in clinical trials. The devices affected by the recall include all lots of the KWP product, and 48551044/5/6/7 and 8 of the OASYS Midline Occiput Plate in sizes small, medium, large, large long, and mini.
Participants in the CerviCore clinical trials have filed a lawsuit against Howmedica-Stryker. They claim that the manufacturer did not properly support patients who experienced difficulties with the device, and did not fully disclose the risks posed by the medical device. Their suit claims that the company said that CerviCore was made entirely of titanium, a basically non-toxic substance. (The white lettering on M&M candies is titanium white.)
But Stryker later admitted that the device actually contained cobalt, molybdenum, chromium, and nickel as well. Cobalt, while it makes a beautiful blue coloring agent, is also one of the most toxic natural substances to earthly life forms.
Why is that such a problem? you might ask. Well, apparently a pin in the device that connected the tulip head to the plate body could fracture, presenting risks of nerve injury, blood loss, and metallosis. The Houston metallosis injury lawyers at Denena Points, PC have written about metallosis before in relation to wear from friction in metal-on-metal hip replacements. The wear results in metal particles in the body that end up getting absorbed by the bloodstream and lodging in organs.
The lawsuit alleges that trial participants are suffering metallosis symptoms. And if they do in fact have cobalt particles flowing through their bloodstreams and lodging in their internal organs, those symptoms could be very serious indeed. The suit also alleges that Stryker has abandoned the clinical trial patients to deal with their symptoms on their own, and that it misrepresented how many of the devices had actually failed during the trials. We note that the trial participants are perhaps in a better position than anyone to know how many of those devices actually failed or caused problems during the clinical trial phase.
At the very least, our Houston metallosis injury lawyers are glad that the FDA did not let this product out onto the market through its expedited approval process. It actually did require clinical trials first. But whether there are trials or not, several manufacturers have shown disturbing tendencies to pay medical professionals to publish positive reviews of their product, to promote unapproved and potentially dangerous off-label uses of their products, and/or to cover up problems and risks related to the devices. The Infuse bone graft product comes to mind.
Medical devices are a huge and growing business. But aggressive marketing strategies that might seem to make good business sense could also lead to risks of deadly complications when the product at issue is one that gets implanted into a person’s body. Use our built-in search function on this web page to find other articles regarding OASYS, Stryker, Infuse, and metallosis.