IFUSE IMPLANT SYSTEM
Received Aug 31, 2023 · Event occurred Sep 8, 2021
Report 3007700286-2023-00002 · MDR key 17666985
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
61 YR · Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, 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 FOR THE FRACTURE COULD NOT BE DETERMINED. BONE FRACTURE IS A KNOWN RISK OF PLACEMENT OF METALLIC DEVICES INTO PELVIC BONE. INITIAL IFUSE PROCEDURE ON 04/26/2021 (BILATERAL): LEFT: IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2765071, MFD. (B)(6)2020, EXP. 2025-01-12, GTIN (B)(6). RIGHT: IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2760611, MFD. (B)(6)2020, EXP. 2025-10-20, GTIN (B)(6).
Description of Event or Problem
IN (B)(6) 2023, SI-BONE REVIEWED CLINICAL STUDY ADVERSE EVENTS AND MADE THE DECISION TO REPORT THIS ADVERSE EVENT ALTHOUGH IT IS UNKNOWN IF THE IMPLANTS WERE THE CAUSE OF THE ADVERSE EVENT. THE PATIENT HAD SPINE FUSION ALONG WITH THE INSTALLATION OF IFUSE IMPLANTS IN (B)(6) 2021. APPROXIMATELY 45 DAYS POST-OP, THE PATIENT PRESENTED WITH SACRAL FRACTURES. THE PATIENT UNDERWENT TWO REVISIONS IN (B)(6) 2021 AND (B)(6) 2022 WHERE SACRAL SCREWS WERE REPLACED. THE IFUSE IMPLANTS WERE NOT ADJUSTED OR REMOVED. BONE FRACTURE IS A KNOWN RISK OF PLACEMENT OF METALLIC DEVICES INTO PELVIC BONE.