IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, 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 AN ALLERGIC REACTION TO TRACE METALS FOUND IN THE IMPLANTS. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE AND GTIN: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2691991, MFD. 08/01/19, EXP. 2024-08-01, GTIN: (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2658981, MFD. 12/10/18, EXP. 2023-12-10, GTIN: (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2692131, MFD. 09/05/19, EXP. 2024-09-05, GTIN: (B)(4).

Description of Event or Problem

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD TWO MONTHS OF PAIN RELIEF BEFORE COMPLAINING OF PAIN. THE PATIENT CLAIMED TO BE ALLERGIC TO NICKEL AND REQUESTED THAT ALL METAL IMPLANTS BE REMOVED. THE PATIENT'S ALLERGY TESTING WAS DONE ELSEWHERE; THE INITIAL SURGEON DID NOT PERFORM ANY ALLERGY TESTING. THE SURGEON AGREED TO REMOVE THE IMPLANTS AS REQUEST BY THE PATIENT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THE IMPLANTS USING CHISELS AS THEY WERE ALL SOLIDLY FIXED IN BONE AND WERE DIFFICULT TO REMOVE. THE SURGEON SAID THAT THE IMPLANTS WERE NOT MALPOSITIONED OR LOOSE AND WERE IN FACT WELL FIXED IN BONE. BONE GRAFT WAS PLACED IN THE EXPLANT VOIDS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.