BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND

    MDR report key: 85870 · Received April 17, 1997

    Report

    Report Number
    2020467-1997-00004
    Event Type
    Injury
    Date Received
    April 17, 1997
    Date of Event
    October 1, 1996
    Report Date
    March 20, 1997
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST STATED THAT WHILE DEBONDING A CERAMIC BRACKET, PT'S TOOTH BROKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention