The FDA announced that it has ordered manufacturers of dynamic stabilization systems (pedicle screw) to begin postmarket surveillance studies to compare dynamic stabilization to traditional stabilization systems relative to fusion rates, adverse events, subsequent surgical procedures, cause of failures of the systems.
From Medical News Today:
Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. Currently, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.
See more at link.
Dynamic stabilization systems have been approved and in use in the U.S. since 1997. No indication was given by the FDA whether there are specific incidents that have triggered the call for postmarket surveillance or if this is a “purely” proactive move by the FDA.
See also the MedMarket Diligence report #M510, “Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017.”
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