BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOFIX RADIOLUCENT WRIST FIXATOR

    MDR report key: 526318 · Received February 17, 2004

    Report

    Report Number
    2183449-2004-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2004
    Date of Event
    January 20, 2004
    Report Date
    February 5, 2004
    Manufacturer
    ORTHOFIX, SRL
    Product Code
    JEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR APPLIED THE FIXATOR FOR TREATMENT OF LEFT DISTAL RADIUS FRACTURE. AT A FOLLOW-UP VISIT ONE WEEK LATER IT WAS NOTICED VIA X-RAYS AND PHYSICAL EXAM THAT THE PT HAD LOST DISTRACTION AND THE CENTRAL BODY LOCKING NUT WAS NOT LOCKED INTO POSITION SECURELY. THE DOCTOR RESET THE FRACTURE IN HIS OFFICE AND LOCKED THE BODY LOCKING NUT IN POSITION. AT THE NEXT FOLLOW-UP APPOINTMENT 13 DAYS LATER IT WAS NOTICED ON X-RAY THAT THE PT HAD AGAIN LOST DISTRACTION. THE DOCTOR CHOSE TO BRING THE PT BACK THE NEXT DAY AND RESET THE FRACTURE AND REPLACE THE FIXATOR BODY IN HIS OFFICE. NO ANESTHESIA WAS USED EITHER TIMES THE FRACTURE WAS RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOFIX RADIOLUCENT WRIST FIXATOR EXTERNAL FIXATION DEVICE JEC ORTHOFIX, SRL 99-36501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR