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The FDA has ordered the manufacturers of new, flexible pedicle screw spinal fusion implants, known as dynamic stabilization systems, to conduct more research on potential problems with the devices, including the whether they provide enough stability to allow for complete spinal fusion and the frequency of additional surgery for patients who receive the pedicle screws.
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In a press release issued on October 5, the FDA expressed concerns that the spine surgery screws may lead to future complications for patients and indicated that they are requiring manufacturers to conduct post-market surveillance studies for existing systems, and premarket clinical trials for systems currently under development.
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New Pedicle Screw Spinal Implants Need
Please note: This article was published more than one year ago.
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