BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS INCORRECT DIAGNOSIS. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBERS, LOT NUMBERS, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-100, LOT# 494222, MFD. 19 AUG 2017, EXP. 2022-08-19, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7040-100, LOT# 493996, MFD. 30 AUG 2017, EXP. 2022-08-30, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-100, LOT# 493996, MFD. 30 AUG 2017, EXP. 2022-08-30, GTIN (B)(4).
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Patient 1
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT CLAIMS TO HAVE NEVER HAD PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE AND WANTED THE IMPLANTS REMOVED. THE PATIENT HAD NO RADICULAR PAIN SYMPTOMS AND THE SURGEON BELIEVES THE IMPLANTS WERE WELL POSITIONED AND NOT LOOSE. IT IS LIKELY THAT IT WAS AN INCORRECT DIAGNOSIS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE IMPLANTS USING CHISELS. THE EXPLANT VOIDS WERE NOT FILLED WITH BONE GRAFT OR OTHER HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.