By: Russell Maas | Published: August 30th, 2013
Government health officials have announced a Class I recall for Stryker Oasys midline occiput plates, after multiple reports were received of postoperative fractures that could lead to potentially fatal health consequences.
The Stryker Oasys is a spinal device that is implanted between the occipital bone and the vertebrae in the cervical spine to provide stabilization and promote fusion of the cervical spine and the occiput t-3.
The Oaysis midline occiput plate recall was first initiated by Stryker on May 30, but the FDA classified the action as a Class I medical device recall on August 29, suggesting that continued use of the product poses a substantial probability of serious injury or death.
If the pin that connets the implant’s tulip head to the plate body breaks, it may cause the patient to suffer pain, weakness, numbness, blood loss, nerve damage, and the need for revision surgery.
Individuals who received a Stryker Oasis spine implant and experience any of these symptoms have been advised to seek immediate medical attention to avoid the risk that their injuries may become life threatening.
The recalled midline occiput plates were manufactured by Stryker Spine of Allendale, New Jersey and distributed from April 23, 2010 through February 12, 2013. The affected OASYS Midline Occiput plates were manufactured in the following five different sizes with correlating part numbers: Small- with part number 48551044, Medium- with part number 48551045, Large- with part number 48551046, Large Long- with part number 48551047, and Mini- with part number 48551048.
Stryker issued an Urgent Medical Device Recall to all known medical facilities to check their inventory for affected plates and to immediately stop distributing or using them and return them to Stryker. Stryker also notified spinal surgeons to quickly evaluate patients who have indicated symptoms of weakness, pain, or numbness. Stryker is also recommending surgeons to contact patients who have received the plate implant and schedule regular check-ups for monitoring.
Users with questions are encouraged to contact Stryker’s Regulatory Compliance Manager and any adverse reactions or complications should be reported to the FDA’s MedWatch program by visiting http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm