OPTIMESH

Additional Manufacturer Narrative

THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.

Description of Event or Problem

THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITHOUT INCIDENT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED SLIGHT POSTERIOR MIGRATION OF THE IMPLANT WITHIN THE DISC SPACE AND PARTIALLY GRAFT MATERIAL EXPULSION INTO THE CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE THE GRAFT MATERIAL AND PERFORM A DECOMPRESSION. FOLLOWING THE REVISION SURGICAL PROCEDURE, THE PATIENT IS REPORTEDLY DOING WELL.