A lawsuit filed against Stryker claims that the OASYS Midline Occiput Plate, a spinal fusion device, causes metallosis in patients who use it.
According to the complaint, a pin connecting the tulip head to the plate body can break, putting patients at risk of blood loss, nerve damage and metallosis. The plaintiffs also accuse Stryker of stating that the device was made entirely from titanium, then later admitting it contained a combination of cobalt, chromium, molybdenum, titanium and nickel.
The OASYS plate was the focus a May 2013 urgent medical device recall and an August Class I recall — the most serious recall category maintained by the FDA.
The plaintiffs include patients who have used the device since its 2010 FDA approval and patients treated during premarket studies. According to the suit, nine of the 14 plaintiffs participated in the original clinical trial.
Stryker began distributing the devices on April 23, 2010, and less than 3 years later an Urgent Medical Device Recall was announced.
The OASYS Midline Occiput Plate was used to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.