BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II CLARITY METAL-REINFORCED CERAMIC BRACKET

    MDR report key: 533629 · Received July 9, 2004

    Report

    Report Number
    2020467-2004-00007
    Event Type
    Injury
    Date Received
    July 9, 2004
    Date of Event
    June 16, 2004
    Report Date
    June 30, 2004
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT DURING THE DEBONDING OF A CLARITY CERAMIC BRACKET, ENAMEL DAMAGE OCCURRED ON PT'S UPPER RIGHT SECOND BICUSPID TOOTH. A PIECE OF ENAMEL, APPROX 4MM X 4MM AND DOWN TO DENTIN, WAS REMOVED. ORTHODONTIST REPORTED THAT ALL OF THE BRACKETS DEBONDED EASILY, INCLUDING THE BRACKET INVOLVED IN THIS EVENT. THE TOOTH WILL BE REPAIRED WITH COMPOSITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention ARCHWIRES, TRANSBOND PLUS SELF-ETCHING PRIMER.| ORTHODONTIC METAL BRACKETS, BUCCAL TUBES,| THERAPY DATES: 2003 TO PRESENT.