BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II CLARITY METAL LINED CERAMIC BRACKET

    MDR report key: 486207 · Received September 26, 2003

    Report

    Report Number
    2020467-2003-00004
    Event Type
    Injury
    Date Received
    September 26, 2003
    Date of Event
    August 1, 2003
    Report Date
    September 16, 2003
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PLAYING FOOTBALL WHEN AN APC II CLARITY BRACKET DEBONDED FROM THE UPPER BICUSPID TOOTH. A PIECE OF ENAMEL 2 1/2 MM X 2 1/2 MM INTO DENTIN WAS REMOVED FROM THE TOOTH WHEN THE BRACKET DEBONDED. ORTHODONTIST SAID THAT TOOTH WILL BE REPAIRED WITH COMPOSITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention BANDS, BUCCAL TUBES, ARCHWIRES.| TRANSBOND PLUS SELF ETCHING PRIMER, METAL BRACKETS