IFUSE TORQ IMPLANT SYSTEM
Received May 13, 2021 · Event occurred Apr 1, 2021
Report 3007700286-2021-00047 · MDR key 11823638
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
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 IS THE SURGICAL PROCEDURE. BLEEDING IS A KNOWN, INHERIT RISK OR SURGERY.
Description of Event or Problem
THE SURGEON WAS PERFORMING A RIGHT SIDE SI JOINT ARTHRODESIS ON THE PATIENT IN (B)(6) 2021 WHEN HE ENCOUNTERED SIGNIFICANT BLEEDING AFTER THE DRILLING STEP BEFORE INSTALLING THE FINAL IMPLANT. AN INTERVENTIONAL RADIOLOGY PHYSICIAN PLACED A COIL TO EMBOLIZE A BRANCH OF THE GLUTEAL ARTERY THAT STOPPED THE BLEEDING. IT IS NOT KNOWN IF THE PATIENT RECEIVED A BLOOD TRANSFUSION OR NOT. PER REPORT OF THE PHYSICIAN VIA THE SALES REP, THE PATIENT SUFFERED NO PERMANENT INJURY. THE RIGHT SIDE SI JOINT ARTHRODESIS WAS COMPLETED WITH THE INSTALLATION OF THREE IMPLANTS. THIS IS A LOW FREQUENCY, LOW RATE OF OCCURRENCE COMPLAINT. THE INCIDENT IS RELATED TO THE SURGICAL PROCEDURE, NOT THE IMPLANTS.