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FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Date:10/5/2009

FDA to request premarket clinical data for new versions of these devices

SILVER SPRINGS, Md., Oct. 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

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.

The FDA is requiring postmarket studies to address these potential risks for systems already on the market. In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

The FDA is not recommending any changes regarding the use of dynamic stabilization systems until it collects and reviews clinical data to better understand how these devices are being used. Patients who have or are considering the implantation of a dynamic stabilization system should consult with their health care practitioner.

Dynamic stabilization systems have different design features that allow bending or rotation while still facilitating fusion. Components used to achieve this flexibility include polymer cords, moveable screw heads, and springs
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SOURCE U.S. Food and Drug Administration
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