Stryker Spine of Allendale, NJ, has 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or 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). During a fusion procedure, the OASYS Midline Occiput Plate is implanted to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
The affected products were distributed from April 23, 2010, through February 12, 2013. On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. On June 20, 2013, Stryker 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 a revision surgery, Stryker recommends routine post-operative care and follow-up.
See the Recall