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 DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: INSTALLING TOO LONG OF AN IMPLANT AND IMPLANT MALPOSITIONING. 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) 2020, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL SURGERY BUT LATER REPORTED RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS TOO LONG AND MALPOSITIONED AND WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE FIRST REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS SOLELY TO ACCESS THE MIDDLE IMPLANT. THERE WERE NO COMPLAINTS ABOUT THE SUPERIOR POSITIONED IMPLANT. HE THEN REMOVED THE MIDDLE POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. HE ALSO INSTALLED A NEW IMPLANT OF THE SAME TYPE IN THE SUPERIOR EXPLANT VOID. THE PREEXISTING INFERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.