BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC FLASH FREE CLARITY SL CERAMIC BRACKET

    MDR report key: 3435416 · Received September 12, 2013

    Report

    Report Number
    2020467-2013-00001
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 15, 2013
    Manufacturer
    3M UNITEK
    Product Code
    NJM
    PMA / PMN Number
    062305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    GENERAL PRECAUTIONS GIVEN BY ORTHODONTISTS TO PATIENTS INCLUDE AVOIDANCE OF EATING ANY HARD OR STICKY FOODS. THE PATIENT ATE A DATE WITH A WALNUT IN IT, AND THE BRACKET BREAKING OFF THE TOOTH AS A KNOWN POSSIBLE CONSEQUENCE. IN ADDITION, THE DEVICE INSTRUCTIONS FOR USE TO THE ORTHODONTIST (THE USER) STATE "INSTRUCT PATIENTS NOT TO CHEW OR BITE ON HARD SUBSTANCES SUCH AS HARD CANDY, ICE, CARROTS, ETC. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS A KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE." THIS OCCURRENCE IS MDR REPORTABLE DUE TO OUR INTERNAL PROCEDURE FOR ANY ENAMEL DAMAGE DOWN TO DENTIN.

    Description of Event or Problem · 1

    PATIENT WITH ORTHODONTIC CERAMIC BRACKETS ATE A DATE WITH A WALNUT IN IT. WHEN SHE BIT DOWN, THE LOWER LEFT 2ND BICUSPID BRACKET BROKE AWAY FROM THE TOOTH, TAKING ENAMEL WITH IT. THE ENAMEL DAMAGE WAS DOWN TO DENTIN, AND THE PATIENT WAS REFERRED TO A DENTIST, WHO RESTORED THE TOOTH USING A RESIN COMPOSITE. THE ORTHODONTIST BANDED THE AFFECTED TOOTH SO THAT ORTHODONTIC TREATMENT COULD CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459869 APC FLASH FREE CLARITY SL CERAMIC BRACKET BRACKET , CERAMIC ORTHODONTIC (NJM) NJM 3M UNITEK NA DQ7QP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ORTHODONTIC ARCHWIRES