IFUSE IMPLANT SYSTEM

Description of Event or Problem

DURING AN INITIAL RIGHT SIDE SI JOINT ARTHRODESIS PROCEDURE, THE SURGEON IMPLANTED THE SECOND IMPLANT SLIGHTLY TOO FAR AND POSSIBLY NEAR THE NEUROFORAMEN. THE SURGEON TRIED TO BACK OUT THE SECOND IMPLANT, BUT THE INSTALLATION/REMOVAL INSTRUMENT BROKE AND THE SURGEON WAS UNABLE TO BACK OUT THE IMPLANT. THE PATIENT WAS FINE FOR TWO DAYS FOLLOWING THE PROCEDURE, BUT LATER REPORTED RADICULAR PAIN. THE PATIENT UNDERWENT REVISION SURGERY A FEW DAYS LATER TO BACK-UP THE SECOND IMPLANT A FEW MILLIMETERS WHICH WAS SUCCESSFUL. THE SURGEON CHOSE TO SKIP STEPS IN THE INSTRUCTIONS FOR USE (DRILLING AND TAPPING). THUS THE PATHWAY INTO WHICH THE IMPLANT WAS TO BE INSERTED WAS INSUFFICIENT AND CREATED EXCESSIVE FRICTION BETWEEN THE IMPLANT AND BONE. THE SURGEON THEREFORE APPLIED EXCESSIVE FORCE TO BACK OUT THE IMPLANT, WHICH RESULTED IN INSTRUMENT BREAKAGE. THE SURGICAL TECHNIQUE MANUAL DESCRIBES DRILLING AND TAPPING PRIOR TO IMPLANT PLACEMENT.

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 IMPLANT FAILURE AND NO INDICATION THAT THE IMPLANT WAS OUT OF SPECIFICATION. THE ROOT CAUSE OF THE POSSIBLE NERVE IMPINGEMENT IS THE INSTRUMENT BREAKING THAT DELAYED THE ADJUSTMENT OR REMOVAL OF THE IMPLANTS. ADDITIONALLY, THE SURGEON CHOSE TO SKIP STEPS IN THE INSTRUCTIONS FOR USE (DRILLING AND TAPPING). THUS THE PATHWAY INTO WHICH THE IMPLANT WAS TO BE INSERTED WAS INSUFFICIENT AND CREATED EXCESSIVE FRICTION BETWEEN THE IMPLANT AND BONE. THE SURGEON THEREFORE APPLIED EXCESSIVE FORCE TO BACK OUT THE IMPLANT, WHICH RESULTED IN INSTRUMENT BREAKAGE. THE SURGICAL TECHNIQUE MANUAL DESCRIBES DRILLING AND TAPPING PRIOR TO IMPLANT PLACEMENT. 1ST (SUPERIOR): IFUSE TORQ, P/N 11550T, LOT 9044042, MFD. 07/06/21, EXP. 2026-07-06, GTIN (B)(4). 2ND (MIDDLE): IFUSE TORQ, P/N 11545T, LOT 9046611, MFD. 09/03/21, EXP. 2026-09-03, GTIN (B)(4). 3RD (INFERIOR): IFUSE TORQ, P/N 11545T, LOT 9043881, MFD. 09/03/21, EXP. 2026-09-03, GTIN (B)(4). T-HANDLE, RATCHETING, QUARTER SQUARE, LOW PROFILE, 0.180 CANNULA, P/N 501518, LOT 661060, GTIN (B)(4). INLINE HANDLE, RATCHETING, QUARTER SQUARE, LOW PROFILE, 0.180 CANNULA, P/N 501519, LOT 661056, GTIN (B)(4).