inforMED
MalfunctionIQI

FEMUR FRACTURE BRACE

Received Dec 12, 2025

Report 3006460162-2025-00080 · MDR key 23792584

Device

Generic name

Femur Fracture Brace

Manufacturer

Orthopediatrics

Product 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. "