BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI DFS DISTAL RADIUS FIXATOR

    MDR report key: 45283 · Received October 24, 1996

    Report

    Report Number
    2242816-1996-00091
    Event Type
    Injury
    Date Received
    October 24, 1996
    Date of Event
    July 26, 1996
    Report Date
    October 23, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD APPLIED FIXATOR TO TREAT A FRACTURE OF THE DISTAL RADIUS. APPROX. TWO WEEKS AFTER APPLICATION, PT RETURNED TO MD'S OFFICE WITH THE PROXIMAL CLAMP COVER LOOSE WHICH RESULTED IN A LOSS OF FRACTURE REDUCTION. THE FIXATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI DFS DISTAL RADIUS FIXATOR Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. 04001 004654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention