BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER ADJUSTABLE RING

    MDR report key: 197220 · Received November 13, 1998

    Report

    Report Number
    1035798-1998-00004
    Event Type
    Malfunction
    Date Received
    November 13, 1998
    Date of Event
    January 1, 1998
    Report Date
    September 18, 1998
    Manufacturer
    BREMER MEDICAL, INC.
    Product Code
    HAX
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN APPLYING THE BREMER ADJUSTABLE RING, THE SKULL PINS WOULD NOT TIGHTEN SUFFICIENTLY AND THE LOCK NUTS SLACKENED WHEN BEING FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER ADJUSTABLE RING ORTHOTIC BRACE HAX BREMER MEDICAL, INC. NA 27095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN