IFUSE IMPLANT SYSTEM
Received Sep 3, 2021 · Event occurred Aug 5, 2021
Report 3007700286-2021-00087 · MDR key 12425010
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
49 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 PSEUDARTHROSIS.
Description of Event or Problem
THE PATIENT HAD A PREVIOUS XLIF (EXTREME LATERAL INTERBODY FUSION). THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR MANY MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED PSEUDARTHROSIS AROUND THE SUPERIOR AND MIDDLE POSITIONED IFUSE IMPLANTS. IN (B)(6) 2021, THE SURGEON REMOVED THE SUPERIOR AND MIDDLE IMPLANTS USING CHISELS. HE THEN INSTALLED NEW HARDWARE INTO EACH OF THE EXPLANT VOIDS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.