IFUSE IMPLANT SYSTEM
Received Aug 26, 2021 · Event occurred Aug 4, 2021
Report 3007700286-2021-00086 · MDR key 12375356
Device
Generic name
Orthopedic Rod
Manufacturer
Si-bone, Inc.Model number
SEE SECTION H.10Lot number
SEE SECTION H.10
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
49 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, 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 AND REPLACE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND UDI/GTIN NUMBER IF APPLICABLE: 1ST (CRANIAL): IFUSE-3D IMPLANT, P/N 7055M-100, LOT# 2694521, MFD. 03 OCT 19, EXP. 2024-10-03, GTIN (B)(4). 2ND (CAUDAL): IFUSE-3D IMPLANT, P/N 7055M-100, LOT# 2692041, MFD. 01 AUG 19, EXP. 2024-08-01, GTIN (B)(4).
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT'S SI JOINT PAIN RESOLVED FOLLOWING THE INITIAL PROCEDURE, BUT THEY LATER REQUESTED THAT ALL IMPLANTS BE REMOVED. THE PATIENT DID NOT HAVE ANY RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH IMPLANTS USING CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. IT IS NOT KNOWN IF BONE GRAFT WAS ADDED TO THE EXPLANT VOID. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE OR MALPOSITIONED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.