The Food and Drug Administration is requiring manufacturers of dynamic stabilization systems used in spinal surgery to help facilitate bone fusion to conduct post-market surveillance studies in order to collect data on potential safety issues.
“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,” according to an agency news release. Failure of the devices could necessitate additional surgeries, according to the FDA.
The agency's ruling will require 16 manufacturers of the systems to conduct post-market surveillance studies. The names of the companies have not been provided, but the FDA said the studies must address the fusion success rates of dynamic stabilization systems compared with traditional stabilization systems; the rates and types of adverse events; the rates of subsequent surgeries; and the causes of failure.