IFUSE IMPLANT SYSTEM
Received Nov 30, 2021 · Event occurred Nov 2, 2021
Report 3007700286-2021-00128 · MDR key 12894340
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
67 YR · Female
- Arthralgia
- Arthralgia
Narrative
Description of Event or Problem
THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE ONE IMPLANT WAS INSTALLED ON EACH SIDE. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE IMPLANTS WERE WELL POSITIONED AND NOT LOOSE BUT DECIDED TO REMOVE AND REPLACE THEM ANYWAY. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH INITIAL IMPLANTS. HE THEN INSTALLED THREE NEW IMPLANTS OF THE SAME TYPE IN EACH SIDE. 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: LEFT: IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2611641, MFD. 12/04/17, EXP. 2022-12-04, GTIN (B)(4). RIGHT: IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2611651, MFD. 08/02/17, EXP. 2022-08-02, GTIN (B)(4).