BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER ADJUSTIBLE RING

    MDR report key: 196948 · Received November 12, 1998

    Report

    Report Number
    1035798-1998-00001
    Event Type
    Malfunction
    Date Received
    November 12, 1998
    Date of Event
    August 26, 1998
    Report Date
    August 27, 1998
    Manufacturer
    BREMER MEDICAL, INC
    Product Code
    HAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RING FROM THE HALO WAS PUT ON THE PT IN ORDER TO PUT THE PT IN TRACTION PRIOR TO PUTTING ON THE HALO VEST. THE ORTHOTIST HAD DIFFICULTY WHEN HE ATTEMPTED TO PUT ON THE TRACTION BALES BECAUSE THE BOLTS WOULD NOT GAIN A PURCHASE ON THE RING. HE USED A COUPLE OF LONGER BOLTS THAT HE HAD IN HIS POSSESSION. THE TRACTION BALE AND RING FUNCTIONED WELL FOR FIVE DAYS, AFTER WHICH TIME THE TRACTION BALE WAS REMOVED AND THE PT PUT IN AN AIRFLO VEST. ONE HALF DAY LATER THE PT NOTED THAT HE COULD MOVE HIS HEAD. WHEN THE ORTHOTIST TRIED TO TIGHTEN THE BOLTS, THEY STRIPPED THE THREADS IN THE RING. WHEN HE TRIED TO TIGHTEN THE OTHER FOUR BOLTS THAT HOLD THE RING TOGETHER, THEY ALSO STRIPEPD. THE HALO VEST WAS REMOVED AND THE PT WAS PUT INTO ANOTHER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER ADJUSTIBLE RING Implant ORTHOTIC BRACE HAX BREMER MEDICAL, INC NA 28761

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR