BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II CLARITY MBT TWIN BRACKET

    MDR report key: 505890 · Received January 9, 2004

    Report

    Report Number
    2020467-2004-00001
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    August 13, 2003
    Report Date
    December 31, 2003
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT A PIECE OF ENAMEL DOWN-TO-DENTIN WAS REMOVED FROM PATIENT'S LOWER RIGHT BICUSPID TOOTH (TOOTH #29) WHEN THE BRACKET DEBONDED WHILE THE PATIENT WAS EATING CHICKEN. ORTHODONTIST STATED THAT PATIENT'S TOOTH HAS BEEN REPAIRED WITH COMPOSITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention TRANSBOND PLUS SELF-ETCHING PRIMER, METAL BRACKETS| 2002 TO 2003.| & ARCHWIRES, BANDS, BUCAL TUBES. THERAPY DATES: