OPTIMESH

Description of Event or Problem

REOPERATION FOR SUDDEN ONSET LEG PAIN, 3 MONTHS POST-OP FOR INTERBODY FUSION. BONE GRAFT WAS SURROUNDING NERVE ROOT. GRAFT AND DEVICE WERE EXPLANTED. AN INTERBODY SPACER WAS PLACED AND A LEFT SIDE PEDICLE SCREW CONSTRUCT WAS ADDED.

Additional Manufacturer Narrative

AT THE INITIAL SURGERY, A UNILATERAL PEDICLE SCREW CONSTRUCT (RIGHT SIDE ONLY) WAS PLACED AFTER THE MESH WAS IMPLANTED AND PACKED WITH BONE GRAFT. REVIEW OF CT SCANS APPEARS TO SHOW THAT THE RIGHT L5 PEDICLE SCREW IS VERY CLOSE, IF NOT INTO, THE FILLED MESH/BONE IMPLANT, AND EITHER THE SCREW OR THE PIN/TAP USED PRIOR TO PLACEMENT OF THE SCREW MAY HAVE CAUSED A TEAR IN THE MESH FABRIC. INFORMATION RECEIVED AT THE TIME OF THE EXPLANT INDICATES THAT THE PATIENT EXPERIENCED A FALL JUST PRIOR TO THE ONSET OF THE LEG PAIN. DAMAGE TO THE DEVICE DURING THE INITIAL SURGERY, COMBINED WITH ADDITIONAL TRAUMA, MAY HAVE LED TO EXPULSION OF SOME BONE GRAFT.