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: 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 SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON INITIALLY THOUGHT THAT THERE MAY HAVE BEEN SLIGHT LUCENCY AROUND THE DISTAL END OF THE SUPERIOR POSITIONED IMPLANT. THE IMPLANT MAY ALSO HAVE BEEN MALPOSITIONED SLIGHTLY TOO ANTERIOR. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE EXPLANT SHOWED SIGNIFICANT GOOD BONE GROWTH ALONG ITS ENTIRE LENGTH AND WAS NOT LOOSE. HE FILLED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.