BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVR PLATE

    MDR report key: 411859 · Received August 16, 2002

    Report

    Report Number
    3003506715-2002-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2002
    Date of Event
    July 18, 2002
    Report Date
    August 14, 2002
    Manufacturer
    HAND INNOVATIONS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002 HAND INNOVATIONS RECEIVED A PHONE CALL FROM AN ORTHOPEDIC SURGEON WHO WANTED TO REMOVE HAND INNOVATION'S DISTAL RADIUS PLATE FROM ONE OF HIS PATIENTS. ACCORDING TO THE SURGEON, THE COMPANY'S PLATE WAS PLACED INSIDE HIS PATIENT'S DISTAL RADIUS IN 2001. THE PATIENT HAD AT THE TIME A HIGHLY COMMINUTED FRACTURE. THE INITIAL REDUCTION WAS QUITE GOOD AND HE STOPPED IMMOBILIZING THE PATIENT 2 WEEKS POST OP. SOMETIMES BETWEEN 6 AND 12 WEEK POST OP THE SCREWS STARTED BREAKING AND THE FRACTURE SLIPPED. WHEN THE DOCTOR CALLED THE COMPANY'S OFFICE HE WAS PLANNING TO EXPLANT THE PLATE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVR PLATE DISTAL VOLAR RADIUS FRACTURE PLATE HRS HAND INNOVATIONS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention