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 USER ERROR; IMPROPER IMPLANT SIZE SELECTION, USING AN IMPLANT THAT WAS TOO SHORT OR NOT INSTALLING THE IMPLANT DEEP ENOUGH. PART NUMBERS, LOT NUMBERS, EXPIRATION DATES AND UDI/GTIN NUMBERS: 2ND (SECOND): IFUSE IMPLANT, P/N 7030-90, LOT# 7628002578001, MFD. 07/07/11, EXP. 2014-07-07, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-90, LOT# 7628002578002, MFD. 07/06/11, EXP. 2014-07-06, (B)(4).
D
Patient 1
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD A PERIOD OF PAIN RELIEF BEFORE REPORTING A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SECOND AND THIRD POSITIONED IMPLANTS WERE NOT FULLY ACROSS THE SI JOINT. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2020, THE SURGEON REMOVED THE SECOND AND THIRD IMPLANTS USING CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE IN A MORE ANTERIOR POSITION TO HELP FIXATE THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.