FDA orders pedicle screw system studies

The screw systems, called dynamic stabilization systems, are used in spinal surgery to provide stabilizing support to the spinal column during bone fusion, the FDA said. The federal agency Monday ordered the manufacturers to conduct surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries.

Officials said there is currently not enough clinical data to determine whether the 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.

In addition, the FDA said it's requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

Agency officials said they are not recommending any changes regarding the use of dynamic stabilization systems at this time and advised patients who have or are considering the implantation of such a system to consult with their healthcare practitioner.

Copyright 2009 by United Press International.