CF BACK PLATE
Received Aug 1, 2025 · Event occurred Jul 17, 2025
Report 8010652-2025-0000030 · MDR key 22684775
Device
Product problems
- Break
- Unintended Movement
- Break
- Unintended Movement
Patient
32 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem
GETINGE BECAME AWARE OF AN ISSUE INVOLVING ONE OF OUR ACCESSORIES ¿ 143334AC - CARBON- FIBRE BACK PLATE FOR SHOULDER. ACCORDING TO THE REPORT, THE ACCESSORY BROKE AT THE END OF THE SURGERY AND FELL TO THE FLOOR. THE INCIDENT OCCURRED WHILE THE PATIENT WAS STILL SEDATED ON THE OPERATING TABLE. THE FALL CAUSED EXTUBATION, AS THE TUBE HOLDER WAS ATTACHED TO THE ACCESSORY. THE PATIENT WAS ASSESSED BY BOTH THE SURGEON AND THE ANESTHESIOLOGIST, WITH NO INJURIES REPORTED. HOWEVER, WE DECIDED TO REPORT THIS ISSUE DUE TO THE POTENTIAL RISK OF SERIOUS INJURY IF A SIMILAR INCIDENT, NAMELY ACCESSORY BREAKAGE LEADING TO THE PATIENT'S EXTUBATION, WAS TO REOCCUR.