BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET

    MDR report key: 6046138 · Received October 20, 2016

    Report

    Report Number
    2020467-2016-00004
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 8, 2016
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    NJM
    UDI-DI
    00652221166005
    PMA / PMN Number
    K102803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR STATES THAT THE TOOTH HAD NO EVIDENCE OF DAMAGE PRIOR TO THE PATIENT'S INITIAL BONDING. THE HYGIENIST WHO PERFORMED THE DEBONDING HAS PERFORMED APPROXIMATELY 1200 DEBONDINGS, AND IS SKILLED AT THE PROCEDURE. 3M UNITEK HAS HAD NO PRIOR INCIDENCES OF A TOOTH BREAKING HORIZONTALLY UPON DEBONDING. IT IS POSSIBLE THAT THE PATIENT EXPERIENCED A BLOW TO THE MOUTH THAT FRACTURED THE TOOTH, BUT IT WAS KEPT INTACT BY THE BRACKET AND THEN BROKE UPON DEBONDING. THE ORTHODONTIST BELIEVES THAT THIS INCIDENT IS AN ANOMALY, AND IS UNSURE OF THE CAUSE.

    Description of Event or Problem · 1

    PATIENT WAS AT ORTHODONTIST TO HAVE BRACES REMOVED AT END OF TREATMENT. UPON DEBONDING THE LOWER RIGHT CENTRAL ANTERIOR BRACKET, THE TOOTH BROKE HORIZONTALLY AT THE LOWER GINGIVAL 3RD. THE PATIENT SAW AN ENDODONTIST, WHO PERFORMED A ROOT CANAL AND PLACED A TEMPORARY CROWN, THEN A PERMANENT CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696425 APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET CERAMIC ORTHODONTIC BRACKET NJM 3M UNITEK CORPORATION UNKNOWN 00652221166005

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention ORTHODONTIC ARCHWIRES