BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON CLEAR

    MDR report key: 2555533 · Received May 1, 2012

    Report

    Report Number
    2016150-2012-00016
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    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

    IT WAS CONFIRMED BY THE DOCTOR THAT THE REST OF THE PATIENT'S UPPER RIGHT BRACKETS WERE REMOVED WITHOUT INCIDENT; THE DOCTOR REMOVED THE OTHER REMAINING BRACKETS WITH A DIAMOND BUR. THE PATIENT WAS SENT TO HER DENTIST THE SAME DAY; ROOT CANAL TREATMENT WAS PERFORMED ON HER #7 TOOTH BY THE DOCTOR AND A TEMPORARY RESTORATION WAS PLACED. THE PERMANENT CROWN WAS PLACED ON (B)(6) 2012. TO DATE, THE PATIENT IS DOING FINE AND HAS NOT ENCOUNTERED ANY PROBLEMS WITH REGARD TO HER CROWN. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WILL NOT BE RETURNED BY THE DOCTOR AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED ENAMEL FRACTURE OF HER #7 TOOTH, UPON THE DEBONDING OF THE UPPER RIGHT DAMON CLEAR BRACKET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R DAMON CLEAR DEBONDING PLIER