IFUSE IMPLANT SYSTEM
Received Dec 1, 2021 · Event occurred Nov 4, 2021
Report 3007700286-2021-00129 · MDR key 12910641
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
43 YR · Female
- Arthralgia
- Arthralgia
Narrative
Description of Event or Problem
THE PATIENT HAD LEFT SIDE JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF CONTINUED SI JOINT PAIN AND REQUESTED THAT THE IMPLANTS BE REPLACED IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE INITIAL IMPLANTS USING CHISELS AS THEY WERE ALL SOLIDLY FIXED IN BONE. HE THEN INSTALLED THREE NEW IMPLANTS OF THE SAME TYPE IN DIFFERENT POSITIONS IN THE LEFT SIDE SI JOINT. THE SURGEON DID NOT INDICATE THAT THE INITIAL IMPLANTS WERE LOOSE OR MALPOSITIONED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.
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 THE IMPLANTS. PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND UDI/GTIN NUMBER IF APPLICABLE: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2591266, MFD. 08/22/2017, EXP. 2022-08-22, GTIN 00851085007374; 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2611631, MFD. 09/25/2017, EXP. 2022-09-25, GTIN 00851085007367; 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7040M-90, LOT# 2611611, MFD. 09/25/2017, EXP. 2022-09-25, GTIN 00851085007343.