MATRIXX SYSTEM

Description of Event or Problem

IMPLANT MIGRATION. SURGEON USED IMPLANT OFF LABEL IN A PROCEDURE THAT CONSISTS OF PEDICLE SCREWS ON ONE SIDE AND A FACET SCREW ON THE CONTRA-LATERAL SIDE. THE PROCEDURE IS TISSUE SPARING FOR THE PATIENT BUT DOES NOT ALLOW BILATERAL COMPRESSION OF THE VERTEBRAL BODIES DOWN ONTO THE INTERBODY IMPLANT. HENCE, THE IMPLANT WAS IMPLANTED IN AN UNBOUND LOCATION AND SUBSEQUENTLY MIGRATED TO A NEW LOCATION. SURGEON CALLED TO ASK FOR ADVICE ON TWO PATIENTS WHEN DESCRIBING THE SCENARIO BUT DID NOT SHARE ANY PATIENT INFORMATION. TWO IDENTICAL MDR'S ARE BEING SUBMITTED TO ACCOUNT FOR EACH PATIENT.