BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND

    MDR report key: 48525 · Received November 8, 1996

    Report

    Report Number
    2020467-1996-00012
    Event Type
    Injury
    Date Received
    November 8, 1996
    Date of Event
    May 1, 1990
    Report Date
    October 21, 1996
    Manufacturer
    3M UNITEK CORP.
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE DEBONDING A CERAMIC BRACKET FROM TOOTH #10, THE CORONAL 2/3 OF THE TOOTH FRACTURED OFF. FOLLOW-UP THERAPY INCLUDED ENDODONTIC TREATMENT AND A PORCELAIN CROWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention STAINLESS STEEL ARCHWIRES 88-5/90| UNITE BONDING ADHESIVE 88-5/90