FDA Recalls Another Medical Device for Spinal Surgery

Medscape Alert
Spinal Fixation System Recalled Due to Potential for Failure


Yael Waknine


April 18, 2006 — The US Food and Drug Administration (FDA) and Blackstone Medical, Inc, have notified healthcare professionals via letter regarding the recall of a modular spinal fixation system (ICON) due to the potential for component failure after device implantation.

The device's pedicle screws may separate from the screw heads, or from the rods that run between spinal segments, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

The FDA notes that the associated potential for injury may vary with the condition being treated and the degree of postoperative healing; if separation occurs soon after surgery, the spine may not fuse properly and further corrective surgery may be required to avoid long-term pain and disability.

Of approximately 484 devices implanted since initial marketing in June 2005, 4% have required surgical removal or revision due to looseness. No deaths or serious injuries other than surgeries required for removal have been reported to the company thus far.

Although the company considers it unlikely that the loosening will continue to occur at this time due to progression of postoperative healing, hospitals and surgeons are requested to contact patients who have received the recalled products.

The fixation system consists of screws, connectors, and rods that form a construct for implantation in and near the patient's spine for the purpose of spinal immobilization and stabilization.

Healthcare professionals are encouraged to report adverse events related to use of the spinal fixation device to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.