BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND

    MDR report key: 187803 · Received September 17, 1998

    Report

    Report Number
    2020467-1998-00005
    Event Type
    Injury
    Date Received
    September 17, 1998
    Date of Event
    April 8, 1994
    Report Date
    September 10, 1998
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST REPORTED THAT WHILE DEBONDING TRANSCEND CERAMIC BRACKETS IN 1994, A HORIZONTAL FRACTURE OCCURRED ON THE UPPER RIGHT LATERAL INCISOR. THE TOOTH BECAME NECROTIC SOME TIME LATER AND SUBSEQUENTLY REQUIRED ROOT CANAL THERAPY IN 1998.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention 03/00/1993 - 04/08/1994.| 3M UNITEK APC ADHESIVE, STAINLESS STEEL BANDS,| BRACKETS, BUCCAL TUBES, ARCHWIRES. THERAPY DATES: