OPTIMESH

Additional Manufacturer Narrative

THE INFORMATION PROVIDED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUAL OR CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.

Description of Event or Problem

REPORT 2135156-2011-00002 REPORTS AN EVENT WHERE THE SURGEON REMOVED PART OF A MESH AND SOME GRAFT DUE TO THE CONSTRUCT BULGING OUT OF THE DISC SPACE. THIS UPDATE IS TO REPORT A SECOND SURGERY IN THIS INCIDENT WHICH OCCURRED ON (B)(6), 2011. THE REST OF THE MESH AND GRAFT WAS REPORTEDLY REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem

PT HAD A SPINAL FUSION PROCEDURE AT L5-S1. FOUR WEEKS POSTOPERATIVELY, THE PT RETURNED WITH NEW LOWER EXTREMITY RADICULAR SYMPTOMS. THE SYMPTOMS DID NOT CHANGE WITH STEROID INJECTIONS. A CT SCAN SHOWED A BULGING MASS PROJECTING OUT OF THE ANNULOTOMY AND INTO THE SPINAL CANAL. THE PT WAS TAKEN BACK TO SURGERY WHERE THE SURGEON NOTED THE MESH AND GRAFT EXTENDED INTO THE CANAL. SOME OF THE MESH FIBERS WERE FRAYED AND CUT. PART OF THE MESH AND GRAFT WAS REMOVED. THE SURGEON NOTED FIRM BONE GRAFT IN THE VENTRAL DISC SPACE. NO NEW GRAFT OR DEVICE WAS INSERTED IN THE DISC SPACE. THE PT'S SYMPTOMS HAVE RESOLVED.