MalfunctionIQI
FEMUR FRACTURE BRACE
Received Dec 12, 2025
Report 3006460162-2025-00080 · MDR key 23792584
Device
Generic name
Femur Fracture Brace
Manufacturer
OrthopediatricsProduct problems
- Unintended Movement
- Unintended Movement
Patient
NA · Unknown
- Malunion of Bone
- Malunion of Bone
Narrative
Description of Event or Problem
ORTHOPEDIATRICS FOUND STATEMENT ON SOCIAL MEDIA THAT STATED "FACEBOOK POST STATED THE BRACE APPEARED PROMISING, BUT IT REPEATEDLY SLIPPED DOWN THE PATIENT'S LEG, CAUSING BONE DISPLACEMENT AND SEVERE PAIN. AS A RESULT, THE PATIENT REQUIRED ANESTHESIA AND WAS PLACED IN A SPICA CAST ABOUT A WEEK AND A HALF LATER, WHICH SIGNIFICANTLY IMPROVED THE SITUATION. "