IFUSE IMPLANT SYSTEM
Received Apr 25, 2025 · Event occurred Mar 18, 2025
Report 3007700286-2025-00002 · MDR key 21914873
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
47 YR · Male
- Hematoma
- Hematoma
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 FOR THE BLEEDING IS THE SURGICAL PROCEDURE.
Description of Event or Problem
PER SI-BONE CMO: THE PHYSICIAN PERFORMED AN SI JOINT FUSION IN (B)(6) 2025. AFTER THE FIRST TWO PINS WERE SUCCESSFULLY PLACED, THE PHYSICIAN EXPERIENCED SIGNIFICANT BLEEDING FROM THE WOUND WHEN USING THE DILATOR. THE PHYSICIAN CONTROLLED THE BLEEDING WITH PRESSURE AND ELECTED TO ABORT THE PROCEDURE. THE PHYSICIAN CLOSED THE INCISION AND PLACED A DRESSING. THE PATIENT LATER PRESENTED TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL WITH A HEMATOMA. THE PATIENT WAS EVALUATED AT THE HOSPITAL. WORK UP INCLUDED AN ANGIOGRAM WHICH SHOWED A PSEUDOANEURYSM. THIS WAS EMBOLIZED DURING THE ANGIOGRAM PROCEDURE. THE PATIENT ALSO RECEIVED A TRANSFUSION. THE PATIENT REMAINED STABLE AND WAS DISCHARGED HOME. THE PATIENT RETURNED TO THE PHYSICIAN OFFICE FOR FOLLOW-UP ON 4/2. AT THIS POINT IN TIME THE PATIENT WAS STABLE AND HAS NO PERMANENT SEQUELAE. THE PATIENT HAS BEEN REFERRED TO ANOTHER PROVIDER.