BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 249427 · Received November 5, 1999

    Report

    Report Number
    2242816-1999-00061
    Event Type
    Malfunction
    Date Received
    November 5, 1999
    Report Date
    November 4, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW-UP VISIT THE MD WANTED TO TAKE THE PATIENT OUT OF DORSEY FLEXION. WHEN HE LOOSENED THE BALL JOINT IT WOULD NOT RETIGHTEN. ANOTHER FIXATOR WAS PLACED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATION HJI EBI MEDICAL SYSTEMS, INC. 04003 133110

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other