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 COULD NOT BE DETERMINED. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANT AT THE PATIENT'S REQUEST. PART NUMBERS, LOT NUMBERS, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7090M-90, LOT# 9010161, MFD. 05/14/19, EXP. 2024-05-14, GTIN (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7065M-90, LOT# 2661651, MFD. 12/18/18, EXP. 2024-12-18, GTIN (B)(4).
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Patient 1
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED NO PAIN RELIEF AND REQUESTED THAT THE IMPLANTS BE SHORTENED. THE SURGEON CONFIRMED VIA CT SCANS THAT THE IMPLANTS WERE PROPERLY POSITIONED BUT DECIDED TO REMOVE AND REPLACE THE IMPLANTS WITH SHORTER IMPLANTS AT THE PATIENT'S REQUEST. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE THEN REMOVED THE SUPERIOR POSITIONED IMPLANT USING THE CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. THE PREEXISTING MIDDLE IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.