IFUSE IMPLANT SYSTEM
Received May 20, 2022 · Event occurred Nov 9, 2021
Report 3007700286-2022-00003 · MDR key 14459717
Device
Generic name
Sacroiliac Joint Fixation
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
60 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
REFERENCE: VOLUNTARY MDR MW5107635: A SURGEON REPORTED GLUTEAL ARTERY BLEEDING OCCURRED UPON THE INSTALLATION OF THE THIRD AND FINAL IMPLANT DURING AN SI JOINT ARTHRODESIS PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT HAS A DYSMORPHIC SACRUM. PER THE MANUFACTURER: THE SURGEON REPORTED BRISK BLEEDING AND A DROP IN HEMOGLOBIN WITH USE OF IFUSE IMPLANT SYSTEM DURING A ROUTINE SI JOINT FUSION. HE SUGGESTS THAT BLEEDING WAS DUE TO SUPERIOR GLUTEAL ARTERY DAMAGE RESULTING FROM DAMAGE RELATED TO EITHER INSTRUMENTS OR THE IMPLANT ITSELF. THIS RISK IS WELL KNOWN. THE RATE OF SEVERE BLEEDING WITH SIJF USING THE IFUSE IMPLANT SYSTEM IS VERY LOW (<0.04%). THERE HAVE BEEN NO CHANGES IN RATE OVER THE PAST FEW YEARS. NO ACTION IS REQUIRED.
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 IS THE SURGICAL PROCEDURE. BLEEDING IS A KNOWN, INHERIT RISK OR SURGERY. THE PATIENT'S ABNORMAL PHYSIOLOGY MAY ALSO HAVE CONTRIBUTED TO THE ADVERSE EVENT. PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND UDI/GTIN NUMBER IF APPLICABLE 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7040M-90, LOT# 2757633, MFD. 09/23/20, EXP. 2025-09-23, GTIN (B)(4). OR 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7045M-90, LOT# 9037751, MFD. 03/01/21, EXP. 2026-03-01, GTIN (B)(4).