OPTIMESH

Description of Event or Problem

PATIENT REPORTED CONTINUED PAIN 2 MONTHS POST-INTERBODY FUSION SURGERY. SURGEON SCHEDULED SURGERY FOR PERCEIVED RECURRENT HERNIATION, BUT WHEN REMOVING WHAT HE THOUGHT WAS A PIECE OF DISC MATERIAL, HE WITHDREW AN INTACT BUT NEARLY EMPTY DEVICE. BONE GRAFT IN THE DISC SPACE WAS EVACUATED AND A NEW DEVICE WAS PLACED AND FILLED WITH GRAFT.

Additional Manufacturer Narrative

IMPLANT WAS EXPLANTED. WHEN REMOVED, THE IMPLANT HAD VERY LITTLE BONE INSIDE. NO OBVIOUS DAMAGED TO MESH BODY OR NECK. SMALL LUMP OF BONY SUBSTANCE IN MESH BODY. ONE PORE APPEARS SLIGHTLY LARGER AT DISTAL END. NOT ENOUGH INFORMATION TO CONCLUDE CAUSE FOR FILLING OUTSIDE OF THE MESH. NO DEVICE DAMAGE OR DEFECT DETECTED.