IFUSE IMPLANT SYSTEM
Received Jul 8, 2022 · Event occurred Mar 9, 2022
Report 3007700286-2022-00004 · MDR key 14962187
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IN (B)(6) 2022, THE SURGEON WAS PERFORMING A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHEN HE ENCOUNTERED SIGNIFICANT BLEEDING AFTER BROACHING/IMPACTING FOR THE SECOND IMPLANT. THE SGA OR A BRANCH WAS POSSIBLY DAMAGED. A SINGLE IMPLANT WAS PLACED ADEQUATELY. WHEN THE INSTRUMENTS WERE REMOVED, THE SURGEON OBSERVED EXCESSIVE BLEEDING. PATIENT UNDERWENT COIL EMBOLIZATION OF BRANCH OF THE SGA BY ANOTHER PHYSICIAN. A WEEK LATER, TWO MORE IMPLANTS WERE PLACED WITHOUT INCIDENT. THIS IS A LOW OCCURENCE EVENT AT <.04% OF ALL PROCEDURES PERFORMED.
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.