Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. According to the FDA, there is currently 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.
As a result, the FDA is requiring postmarket studies to address these potential risks for class II dynamic stabilization 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 has required the manufacturers of 16 dynamic stabilization systems or components on the market for spinal fusion to conduct postmarket surveillance studies, which must address the following:
• 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; and
• 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.
Read the FDA release on the postmarket surveillance studies for spinal surgery dynamic stabilization systems.
