On May 30, 2013, Stryker Orthopaedics issued an Urgent Class I Recall regarding its OASYS Midline Occiput Plate to hospitals and medical facilities. The device was found to have post-operative fractures of the pin that connects the tulip head to the body of the plate. This fracture has been linked to adverse health risks such as blood loss, nerve injury and the need for revision surgery to replace the fractured implant.
On June 20, 2013, Stryker notified surgeons that had implanted the device to conduct routine clinical and radiographic post-operative evaluations of their patients. Stryker also advised surgeons that patients who experience pain, weakness or numbness should be seen for more urgent evaluations.
The OASYS Midline Occiput Plate is used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). It provides stabilization at the junction between the occipital bone and the vertebrae of the cervical spine. The device first received FDA approval through the 510(k) submission process in February 2004. The affected units were distributed between April 23, 2010 and February 12, 2013.
The FDA 510(k) submission process allows manufacturers to receive approval to sell and market its device by indicating to the FDA that the device is “substantially similar” to another product already being produced on the market. Devices approved through the 510(k) process do not have to go through the rigorous testing and screening required by the FDA for new products approved through the pre-market approval (PMA) process.
If you or a loved one has had the OASYS Midline Occiput Plate installed, please contact your doctor immediately. Also, please consider contacting us at 1-800-247-1623 or firstname.lastname@example.org to discuss your legal rights.