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: USING TOO LONG OF AN IMPLANT OR INSTALLING THE IMPLANT TOO DEEP. ADDITIONALLY, PER (B)(4) (US), SI-BONE SURGICAL TECHNIQUE MANUAL (C-ARM AND O-ARM), 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 (B)(6) 2016 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE NEW SURGEON DETERMINED BASED ON THE IMAGING REPORTS THAT THE MIDDLE-POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IFUSE IMPLANT USING THE IFUSE REMOVAL ADAPTER AS IT WAS SOLIDLY FIXED IN BONE. THE IMPLANT WAS REPLACED WITH A SHORTER IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.