IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS MALPOSITIONED IMPLANT DUE TO ALTERED PELVIC ANATOMY FROM A PREVIOUS TRAUMA INCIDENT. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL, THE SURGEON IS INSTRUCTED AS FOLLOWS: "PRIOR TO CLOSURE, ALWAYS OBTAIN FINAL FLUOROSCOPIC IMAGES IN THE LATERAL, INLET, AND OUTLET VIEWS TO CONFIRM NO CORTICAL WALL BREACH, FORAMEN BREACH, OR OTHER MALPOSITION."

Description of Event or Problem

THE PATIENT HAD A PREVIOUS AUTOMOBILE TRAUMA PELVIC INJURY TREATED WITH PUBIC SYMPHYSIS PLATING AND ILIOSACRAL SCREW FIXATION. THE PATIENT HAD A COLLAPSED STRUCTURE OF THE SACRAL ALA BECAUSE OF THE ORIGINAL INJURY. IN (B)(6) 2021, THE SURGEON PERFORMED A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHERE THREE IMPLANTS WERE INSTALLED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO IMMEDIATE POST-OPERATIVE COMPLICATIONS. THE PATIENT LATER REPORTED WEAKNESS OF THE LEFT ANKLE DORSI AND PLANTAR FLEXION. THE SURGEON DETERMINED DISPLACEMENT OF THE L5 NERVE ROOT SO THAT IT WAS POSITIONED IN AN ADHERENT LOCATION IN THE VICINITY OF THE SUPERIOR POSITIONED IMPLANT. THE ALTERED ANATOMY OF THE SACRAL ALA BECAUSE OF THE TRAUMATIC PELVIC RING FRACTURE SIGNIFICANTLY CONTRIBUTED TO THE L5 NERVE IRRITATION/INJURY. THE ALTERED PELVIC ANATOMY MAY HAVE MADE IMAGING DIFFICULT DURING THE IMPLANT INSTALLATION PROCEDURE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO ADDITIONAL HARDWARE WAS ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT WAS DOING WELL FOLLOWING THE REVISION PROCEDURE.