BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND CERAMIC BRACKET

    MDR report key: 63245 · Received January 10, 1997

    Report

    Report Number
    2020467-1997-00001
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    December 12, 1996
    Report Date
    December 16, 1996
    Manufacturer
    3M UNITEK
    Product Code
    ECQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST STATED THAT WHILE DEBONDING A TRANSCEND CERAMIC BRACKET FROM TOOTH #11, THE TOOTH FRACTURED AT THE GINGIVAL ONE-THIRD ON THE FACIAL AND SUBGINGIVAL ON THE LINGUAL AND DISTAL. FOLLOW-UP THERAPY INCLUDED ENDODONTIC TREATMENT AND A CROWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention TRANSCEND DEBONDED (#444-770),| STAINLESS STEEL ARCHWIRE,| BONDING ADHESIVE,| ORTHODONTIC TREATMENT