BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI SPORTS MEDICINE

    MDR report key: 250409 · Received November 15, 1999

    Report

    Report Number
    2242816-1999-00063
    Event Type
    Malfunction
    Date Received
    November 15, 1999
    Date of Event
    November 1, 1999
    Report Date
    November 11, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 2 WEEKS AFTER ACL SURGERY, THE PT WAS STEPPING DOWN OFF A STEP LADDER WHEN THE POST-OP BRACE "COLLAPSED". THERE WAS NO INJURY TO THE PT. THE POST-OP BRACE WAS REPLACED WITH A DIFFERENT TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI SPORTS MEDICINE BRACE ITQ EBI MEDICAL SYSTEMS, INC. 137005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other