BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II CLARITY ADVANCED CERAMIC BRACKET

    MDR report key: 5510773 · Received March 18, 2016

    Report

    Report Number
    2020467-2016-00002
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 24, 2016
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    NJM
    PMA / PMN Number
    K102803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT STATED SHE HAD NO IDEA HOW OR WHEN THE INCIDENT HAPPENED. THE BRACKET DID NOT FALL OFF, AS IF THE BOND FAILED, THERE WOULD BE NO ENAMEL DAMAGE. SOME SORT OF FORCE HAD TO BE APPLIED TO DISLODGE THE BRACKET AND ENAMEL FROM THE TOOTH. ORTHODONTISTS ROUTINELY CAUTION PATIENTS WITH CERAMIC BRACKETS NOT TO CHEW OR BITE ANYTHING HARD. THE IFU FOR CLARITY ADVANCED BRACKETS CONTAINS A WARNING: "INSTRUCT PATIENTS NOT TO CHEW OR BITE ON HARD SUBSTANCES SUCH AS HARD CANDY, ICE, CARROTS, ETC. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS THE KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE." WHEN CERAMIC BRACKETS ARE DEBONDED PROPERLY BY THE ORTHODONTIST, ENAMEL DAMAGE RARELY OCCURS. IT IS SURMISED THAT THE CAUSE OF THE INCIDENT WAS THE PATIENT BITING/CHEWING SOMETHING HARD.

    Description of Event or Problem · 1

    PATIENT WENT TO ORTHODONTIST FOR REPAIR OF A LOOSE BRACKET, WHICH WAS STILL ATTACHED TO THE ARCHWIRE. THE BRACKET HAD DEBONDED AND A PIECE OF ENAMEL REMAINED ON THE BRACKET BASE. ACCORDING TO THE ORTHODONTIST, THE DAMAGE WAS DEEP INTO DENTIN. HE BONDED THE BROKEN PIECE OF ENAMEL, STILL ATTACHED TO THE BRACKET, BACK INTO PLACE ON THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165691 APC II CLARITY ADVANCED CERAMIC BRACKET CERAMIC BRACKET NJM 3M UNITEK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention