BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND CERAMIC BRACKET

    MDR report key: 514418 · Received March 3, 2004

    Report

    Report Number
    2020467-2004-00003
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    February 21, 1991
    Report Date
    February 19, 2004
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT WHILE DEBONDING TRANSCEND CERAMIC BRACKETS IN 1991, ENAMEL DAMAGE DOWN TO DENTIN OCCURRED ON PT'S RIGHT UPPER CENTRAL TOOTH. THE TOOTH WAS REPAIRED WITH COMPOSITE IN 1991. HOWEVER, A CROWN WAS PLACED ON THE TOOTH IN 2004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention THERAPY DATES: 1990 TO 1991| COMPOSITE BONDING ADHESIVE.