Updated August 30, 2013, at 4:00 p.m. with comments from Stryker.
The FDA issued a Class I recall for 5 lots of Stryker Spine’s Oasys Midline Occipital Plate, warning patients and physicians that the device might fracture after surgery.
Class I recalls are the most serious type, reserved for product issues that can lead to serious adverse health consequences or death. Pin fracture in the recalled Oasys plates can cause blood loss, nerve injury, and the need for revision surgery to replace the fractured implant, according to the FDA notice.
The recalled Oasys plate, which was also the subject of a recent recall Down Under, is intended to stabilize the junction between the occipital bone and the vertebrae in the cervical spin.
Stryker originally began warning doctors of the issue in February, according to a company statement sent to MassDevice.com today. The device maker asked doctors to stop using the devices completely and not to order any new units after post-market surveillance of product complaints revealed the breakage issue, according to Stryker.
The company initiated an urgent recall of the device on May 30 after hearing that the pins that connect the tulip heads to the plate bodies had fractured post-operatively in some patients, the FDA said. Stryker has asked medical facilities to examine their inventory, immediately stop distributing or using the recalled lots and to return any affected product in stock to the company.
Stryker sent out an additional notification to spinal implant surgeons on June 20, recommending routine clinical and radiographic post-operative evaluation for patients with an implanted Oasys Midline plate, the FDA noted. In that letter the company called for more urgent evaluation of patients who are experiencing symptoms including pain, weakness or numbness.