inforMED
InjuryHRS

LOQTEQ® RECONSTRUCTION PLATE 3.5, 7 HOLES, L 82

Received Feb 27, 2024 · Event occurred Jan 9, 2024

Report 3001406084-2024-00001 · MDR key 18788019

Device

Generic name

Bone Plates

Manufacturer

Aap Implantate Ag

Model number

PR 3550-07-2

Lot number

T024

Product problems

  • Off-Label Use
  • Off-Label Use

Patient

20 YR · Male

  • Bone Fracture(s)
  • Bone Fracture(s)

Narrative

Description of Event or Problem

A RECONSTRUCTION PLATE WAS USED TO TREAT A MID-SHAFT FRACTURE OF THE RADIUS. THE PLATE BROKE 3.5 MONTHS AFTER TREATMENT DUE TO A FALL DURING A SPORTING ACTIVITY (SOCCER). THE PATIENT WAS TREATED IN REVISION SURGERY AND THE OSTEOSYNTHESIS IS STABLE.

Remedial action

  • Replace