BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON CLEAR

    MDR report key: 2098193 · Received May 20, 2011

    Report

    Report Number
    2016150-2011-00093
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ORMCO CORPORATION
    Product Code
    NJM
    PMA / PMN Number
    K081415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S TOOTH WAS REPAIRED AND A NEW DAMON CLEAR BRACKET WAS PLACED. THE PATIENT IS DOING FINE. THE DOCTOR STATED THAT THE BRACKET WAS PLACED IN THE MIDDLE OF THE TOOTH AND AN ETM BRACKET REMOVAL PLIER, AND NOT A DAMON CLEAR DEBONDING INSTRUMENT AS RECOMMENDED IN THE DAMON CLEAR DEBONDING PROTOCOL, WAS USED TO DEBOND THE BRACKET. IT CAN THEREFORE BE CONCLUDED THAT USER ERROR CONTRIBUTED TO THIS INCIDENT. NO PRODUCT WAS RETURNED FOR EVALUATION AND NO PART NUMBER OR LOT NUMBER WERE PROVIDED THEREFORE NO FURTHER INVESTIGATION CAN TAKE PLACE.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR REPORTED TO ORMCO CORPORATION THAT A PATIENT EXPERIENCED ENAMEL LOSS UPON DEBONDING A DAMON CLEAR BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON CLEAR ORTHODONTIC PLASTIC BRACKET NJM ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ETM BRACKET REMOVAL PLIER