BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY APC METAL-REINFORCED CERAMIC BRACKET

    MDR report key: 228009 · Received June 17, 1999

    Report

    Report Number
    2020467-1999-00001
    Event Type
    Injury
    Date Received
    June 17, 1999
    Date of Event
    July 20, 1998
    Report Date
    June 1, 1999
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST STATED THAT IN AN ATTEMPT TO REMOVE A FRACTURED PORTION OF A BRACKET, A HORIZONTAL FRACTURE OF TOOTH #25 OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY APC METAL-REINFORCED CERAMIC BRACKET ORTHODONTIC BRACKET DYW 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention THERAPY DATES: 08-15-97 TO 07-20-98.| ARCHWIRES, METAL BRACKETS, AND BUCCAL TUBES,| TRANSBOND XT ADHESIVE, DEBONDING PLIER.