Back in May, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory of five product codes of its OASYS Midline Occiput plate. Now the FDA has upgraded the recall to class I status, its highest category and indicative that the device, if used could have serious healthcare consequences, including death.
The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
The reason for recalling the products is that Stryker had received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
Specific product codes affected are listed on the FDA recall notice, here, and include small, medium, large, large/long and mini iterations.
As far back as June, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate. It said that if a patient begins experiencing symptoms including pain, weakness, or numbness, more urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.