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: IMPROPER INITIAL IMPLANT SIZE SELECTION, USING TOO LONG OF AN IMPLANT OR NOT IMPLANTING THE IMPLANT DEEP ENOUGH. ADDITIONALLY, PER 300223-A (US), SI-BONE SURGICAL TECHNIQUE MANUAL: "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." PART NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE AND GTIN: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2731651, MFD. 03/30/2020, EXP. 2025-03-30, GTIN (B)(4). 2ND (INFERIOR): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2728321, MFD. 03/05/2020, EXP. 2025-03-05, GTIN (B)(4).

Description of Event or Problem

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS AND SWELLING ON RIGHT LEG. THE NEW SURGEON DETERMINED THAT THE IMPLANTS WERE TOO PROUD OF THE ILIUM, IRRITATING THE MUSCLE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH THE IMPLANTS USING CHISELS. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT AND NO NEW HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.