BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON CLEAR

    MDR report key: 1903937 · Received November 20, 2010

    Report

    Report Number
    2016150-2010-00189
    Event Type
    Injury
    Date Received
    November 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ORMCO CORPORATION
    Product Code
    NJM
    PMA / PMN Number
    K081415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR'S OFFICE REPORTED THAT THE DEBONDING OF A DAMON CLEAR BRACKET CAUSED ENAMEL DELAMINATION WHEN A DOCTOR REMOVED IT FOR REPOSITIONING. THE TOOTH WAS REPAIRED AND RE-PREPPED AND A NEW DAMON CLEAR BRACKET WAS BONDED. THE PATIENT IS DOING FINE. THE DOCTOR STATED THAT WHEN THE BRACKET WAS INITIALLY PLACED, HE APPLIED ORTHO SOLO PLUS TO BOTH THE TOOTH AND THE BRACKET. THIS GOES AGAINST THE INSTRUCTIONS FOR USE FOR ORTHO SOLO PLUS WHICH STATES THAT IT SHOULD BE APPLIED TO ONLY THE TOOTH, AS APPLYING EXCESS PRIMER BEYOND THE INSTRUCTED USAGE WILL INCREASE BOND STRENGTH AND COULD SUBSEQUENTLY RESULT IN ENAMEL DAMAGE UPON DEBONDING. A VISUAL INSPECTION OF THE RETURNED BRACKET INDICATED THAT AN EXCESS AMOUNT OF ADHESIVE WAS APPLIED WHICH ALSO INCREASES BONDING FORCES AND CAN ALSO RESULT IN ENAMEL DAMAGE UPON DEBONDING. THE VISUAL INSPECTION ALSO INDICATED THAT THE BRACKET WAS PLACED VERY CLOSE TO THE GINGIVA. THE LOCATION OF THE BRACKET MAY HAVE LIMITED THE ACCESS OF THE DEBONDING INSTRUMENT, RESULTING IN POOR POSITIONING OF THE DEBONDING TOOL AND SUBSEQUENT ENAMEL DAMAGE. THE RESULTS OF THE INVESTIGATION INDICATE THAT THE CAUSE FOR THE ENAMEL DAMAGE WAS DUE USER ERROR AND NOT TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON OCTOBER 20, 2010, 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 TRANSBOND XT| ORTHO SOLO PLUS| DAMON CLEAR DEBONDING INSTRUMENT