IFUSE IMPLANT SYSTEM
Received May 11, 2021 · Event occurred Apr 13, 2021
Report 3007700286-2021-00042 · MDR key 11809644
Device
Generic name
Orthopedic Rod
Manufacturer
Si-bone, Inc.Model number
SEE SECTION H.10Lot number
SEE SECTION H.10
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
72 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU 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 IMPLANT LATE LOOSENING. PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND GTIN NUMBER: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7040-90, LOT# 493887, MFD. 05/04/2017, EXP. 2022-05-04, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7035-90, LOT# 493895, MFD. 04/30/2017, EXP. 2022-04-30, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7030-90, LOT# 493967, MFD. 06/13/2017, EXP. 2022-06-13, GTIN (B)(4).
Description of Event or Problem
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD GOOD SI JOINT PAIN RELIEF FOR FOUR YEARS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING OF THE IMPLANTS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE IMPLANTS. THE EXPLANT VOIDS WERE NOT FILLED WITH BONE GRAFT AND NO NEW HARDWARE WAS INSTALLED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.