BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON Q

    MDR report key: 1891926 · Received November 5, 2010

    Report

    Report Number
    2016150-2010-00183
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR'S OFFICE REPORTED THAT THE DE-BONDING OF A DAMON Q BRACKET CAUSED ENAMEL DELAMINATION. NO SPECIFIC DETAILS WERE PROVIDED ON THIS INCIDENT, HOWEVER IT WAS STATED THAT THE TOOTH WAS REPAIRED WITH COMPOSITE AND THE PATIENT IS DOING FINE. THE BRACKET HAS BEEN RETURNED TO ORMCO CORPORATION AND AN INVESTIGATION IS IN PROGRESS. WHEN EVALUATION RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON OCTOBER 7, 2010, A DOCTOR REPORTED TO ORMCO CORPORATION THAT A PATIENT EXPERIENCED ENAMEL LOSS WHEN A DAMON Q BRACKET DEBONDED. THIS IS THE THIRD OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON Q BRACKET, METAL, ORTHODONTIC EJF ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RELIANCE PHASE II ADHESIVE