GRAFTON ORTHOBLEND - LARGE DEFECT

Description of Event or Problem

IT WAS REPORTED THAT THE PT REC'D AN ALLOGRAFT BONE VOID FILLER IMPLANT DURING AN L5 - S1 FUSION WITH ARTHRODESIS TO TREAT HIS BILATERAL L5 PARS FRACTURE WITH L5 ON S1 SPONDYLODESIS, BILATERAL L5 RADICULOPATHY AND SPINAL STENOSIS. THE PROCEDURE WAS REPORTED TO HAVE NO COMPLICATIONS. AT APPROX 6 WEEKS POST-OP, THE SURGEON OBSERVED A BROKEN S1 PEDICLE SCREW ON X-RAY, WHICH WAS CONFIRMED ON CT SCAN, STATING IT LOOKED LIKE "THE HEAD HAS JUST POPPED OFF," BUT NOTED "GOOD FUSION FOR BEING ONLY SIX WEEKS OUT." APPROX ELEVEN WEEKS POST-OP, THE PT RETURNED TO THE DOCTOR WITH QUITE A BIT OF PAIN. SURGEON OFFERED THE PT SURGERY TO REVISE THE SCREW BREAKAGE, BUT INDICATED SHE DID NOT FEEL THE REVISION WOULD CHANGE ANYTHING, GIVEN THAT THE PT WAS "HEADED TOWARDS A GOOD BONY UNION." PT WAS PRESCRIBED PHYSICAL THERAPY AND PAIN REHAB.

Additional Manufacturer Narrative

(B)(6). THE MFG RECORDS FOR THE SUBJECT LOT OF PRODUCT WERE REVIEWED. THE PRODUCT WAS CONFIRMED TO HAVE BEEN MANUFACTURED PER PROCEDURE AND MET ALL SPECIFICATIONS AND RELEASE CRITERIA. NO ADD'L REPORTS OF THIS NATURE HAVE BEEN REC'D INVOLVING ANY OTHER GRAFTS MANUFACTURED IN THIS LOT OF PRODUCT. OSTEOTECH'S (B)(4) HAS REVIEWED THE PT MEDICAL RECORDS AND DETAILS OF THIS CASE, AND CONCLUDED THAT THE SUBJECT GRAFT MATERIAL COULD NOT HAVE CONTRIBUTED TO THE FAILURE OF THE PEDICLE SCREW. OSTEOTECH IS FILING THIS MDR FOR NOTIFICATION PURPOSES. ALSO SEE MEDWATCH REPORT NUMBER 1030489-2012-01038.