BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL END CUTTER

    MDR report key: 1911401 · Received November 24, 2010

    Report

    Report Number
    2086211-2010-00123
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DENTSPLY GAC
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT THE TIP OF A DISTAL END CUTTER SEPARATED; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL END CUTTER EJB DENTSPLY GAC 08-25-1

    Patients

    Seq Age Sex Outcome Treatment
    1 OFFICE USES WIRES UP TO .019X .025 SS