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FDA Orders Post-Market Surveillance Studies on Spinal Systems

Afterwards, agency will decide whether labeling changes or more clinical testing requirements will be necessary.

By: Editor

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The U.S. Food and Drug Administration (FDA) has ordered 16 pedicle screw system manufacturers to conduct post-market surveillance studies to collect clinical data on safety issues, including fusion rates and frequency of additional surgeries, according to the agency.

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, the agency said in a press release. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.

The FDA is requiring post-market studies to address these potential risks for systems already on the market. In addition, the agency 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 their doctors.

The manufacturers must address these issues in their post-market studies, according to the FDA:

• The fusion rate for dynamic stabilization systems compared to traditional stabilization systems

• The incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems

• The type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems

• The cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

The FDA will consider whether labeling changes or additional preclinical and clinical testing requirements are necessary for these devices.

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