Stryker Spine is warning doctors and patients of a defect with the OASYS Midline Occiput Plate, which is used in spinal surgery to stabilize the skull and spine at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine. It has been identified that, after surgery, the pin that connects the tulip head to the plate can break, which can lead to destabilization of the plate. This could cause serious health consequences including blood loss, nerve injury and revision surgery to repair the problem.
Stryker has sent an Urgent Medical Device Recall notice to medical facilities who have received the devices, requesting that they examine their inventory and immediately stop distributing or using the recalled lots. Medical facilities with any of the recalled products in stock should immediately return them to Stryker.
Stryker has also notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate. If a patient begins experiencing symptoms including pain, weakness or numbness, more urgent evaluation is needed. For patients who have had revision surgery, Stryker recommends routine post-operative care and follow-up.
The OASYS Midline Occiput Plate recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is reasonable probability that use of the products will cause serious adverse health consequences or death.
Any adverse events associated with this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.