BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER

    MDR report key: 2246652 · Received September 8, 2011

    Report

    Report Number
    1032227-2011-00005
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BRASSELER USA
    Product Code
    DZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE EVENT WAS RETURNED. AN INVESTIGATION IS CURRENTLY IN PROCESS. WHEN THE INVESTIGATION IS COMPLETED, THE RESULTS WILL BE REPORTED.

    Description of Event or Problem · 1

    PARTS OF THE DIAMOND COATING ON A BUR HAD SEPARATED FROM THE BASE, LODGED IN BONE AND 'REQUIRED EXTENSIVE SURGERY TO REMOVE THE SECTIONS' FROM A PT. THE BUR WAS BEING USED TO GO IN ALONGSIDE THE TOOTH TO REMOVE SOMETHING WHEN THE DIAMOND COATING SEPARATED FROM THE BUR. IT TOOK ABOUT AN HOUR TO REMOVE TWO OF THE PIECES WITH AN ENDODONTIC EXPLORER WHILE THE PT WAS STILL IN THE CHAIR. THERE WAS ONE MORE PIECE (THE TIP) REMAINING IN THE PT. THE PT IS FULLY AWARE OF ITS PRESENCE AND POSSIBLE COMPLICATIONS. THE DOCTOR BELIEVES IT WILL BE INERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER DZP BRASSELER USA 859.36.010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention