Spine Devices to Get Post Market Safety Review

The FDA has called for a post-market safety review of certain dynamic-stabilization devices used in spine surgeries. The review concerns questions about their safety and their effectiveness in the device’s fusion rate compared to more traditional procedures. The study will try to determine the rate at which these dynamic-stabilization devices fail to fuse, break, or loosen over time. Problems with the medical devices could require further surgery and spinal complications for the patient. The devices in question are manufactured by Johnson & Johnson (JNJ) and Zimmer Holdings Inc.
The newer spine stabilization systems which were first introduced 12 years ago provide some flexibility while the older systems are more rigid. The FDA, in calling for the post market safety review, wants to determine the safety records of such devices now that they are being used by healthcare professionals. Of course, this process would be much easier if the FDA had some sort of medical device registry in place. However, Congress is working on such legislation in collaboration with the federal agency.