BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER ADJUSTIBLE RING

    MDR report key: 196961 · Received November 12, 1998

    Report

    Report Number
    1035798-1998-00002
    Event Type
    Malfunction
    Date Received
    November 12, 1998
    Date of Event
    January 1, 1998
    Report Date
    October 12, 1998
    Manufacturer
    BREMER MEDICAL, INC.
    Product Code
    HAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE APPLYING RING TO PT, CONNECTING BOLT, WHICH ATTACHES RING TO THE SUPERSTRUCTURE, PULLED OUT OF RING THREADS. SURGEON APPLIED LOCK NUT WHICH HELD UNIT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER ADJUSTIBLE RING ORTHOTIC BRACE HAX BREMER MEDICAL, INC. NA 28092

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN