IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: MALPOSITIONING OF THE INITIAL IMPLANT. 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

IN (B)(6) 2021, THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS WHERE ONE IMPLANT WAS INSTALLED ON EACH SIDE. THE PATIENT REPORTED CONTINUED LEFT SIDE SI JOINT PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE IMPLANT WAS MALPOSITIONED AND NOT FULLY ACROSS THE SI JOINT. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT AND INSTALLED A NEW IMPLANT OF THE SAME TYPE AND LENGTH IN A MORE POSTERIOR APPROACH. HE THEN INSTALLED AN ADDITIONAL IMPLANT IN THE LEFT SI JOINT TO HELP STABILIZE THE JOINT. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.