FDA Orders Post-Market Review Of Spinal Screws

Law360, New York (October 7, 2009, 3:09 PM EDT) -- The U.S. Food and Drug Administration has ordered manufacturers of certain dynamic stabilization systems — a type of pedicle screw system — to conduct post-market surveillance and clinical studies on the safety of the systems.

The FDA ordered makers of 16 currently marketed dynamic stabilization systems, which are used to hold segments of the spine in place while they fuse after surgery, to collect data on how effective their products are and how often patients require additional surgery.

Dynamic stabilization systems implanted temporarily to aid bone...
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