IFUSE IMPLANT SYSTEM
Received Sep 10, 2021 · Event occurred Aug 17, 2021
Report 3007700286-2021-00092 · MDR key 12457260
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
59 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, 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 AT THE PATIENT'S REQUEST.
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR ONE YEAR BEFORE COMPLAINING OF A RECURRENCE OF PAIN AND REQUESTING THAT ALL THE IMPLANTS BE REMOVED. THE SURGEON DID NOT INDICATE ANY MEDICAL REASON TO REMOVE THE IFUSE IMPLANTS BUT AGREED TO REMOVE THEM IT AT THE PATIENT'S REQUEST. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE IMPLANTS USING CHISELS AS THEY WERE ALL SOLIDLY FIXED IN BONE. ALL REMOVED IMPLANTS SHOWED GOOD BONE IN/ON-GROWTH. THE EXPLANT VOIDS WERE NOT FILLED WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.