IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: USING TOO LONG OF AN 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

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN 2019 OR 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF RADICULAR PAIN. THE NEW SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS BREACHING THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN JUNE 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. AN ADDITIONAL IMPLANT OF THE SAME TYPE WAS ALSO ADDED TO HELP FIXATE THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.