BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI SPORTS MEDICINE

    MDR report key: 255665 · Received December 17, 1999

    Report

    Report Number
    2242816-1999-00066
    Event Type
    Malfunction
    Date Received
    December 17, 1999
    Date of Event
    November 1, 1999
    Report Date
    December 14, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVERAL MONTHS POSTOPERATIVELY, THE PT WAS WALKING WHEN THE HINGE ON HIS BRACE BROKE. THERE WAS NO INJURY TO THE PT. ALTHOUGH THERE WAS NO INJURY TO THE PT A REPORT IS BEING FILED FOR INFORMATIONAL PURPOSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other