BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRICTION - STOP ADJUSTABLE FACEBOW

    MDR report key: 360157 · Received October 31, 2001

    Report

    Report Number
    2020467-2001-00007
    Event Type
    Malfunction
    Date Received
    October 31, 2001
    Date of Event
    September 20, 2001
    Report Date
    October 4, 2001
    Manufacturer
    3M UNITEK
    Product Code
    DZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT WHILE PT WAS ASLEEP, THE FACEBOW BROKE AND PT SWALLOWED A FRAGMENT OF THE FACEBOW. THE PT WAS EXAMINED AT THE HOSP EMERGENCY ROOM AND HAD A RADIOGRAPHY TO ESTABLISH THE POSITION OF THE METAL FRAGMENT. PT WAS GIVEN AN ANTI-INFLAMMATORY MEDICATION TO TAKE (THE ORTHODONTIST BELIEVES IT WAS A GENERIC NON-PRESCRIPTION DRUG). A SECOND RADIOGRAPHY WAS DONE IN ORDER TO CONFIRM THAT THE WIRE FRAGMENT HAD PASSED THROUGH THE PT'S INTESTINAL TRACT. NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48706 FRICTION - STOP ADJUSTABLE FACEBOW ORTHODONTIC FACEBOW DZB 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR ADHESIVE, HEADGEAR. THERAPY DATE: 2000 TO PRESENT.| ORTHODONTIC BRACKETS, BUCCAL TUBES, ARCH WIRE,