BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL END CUTTER

    MDR report key: 1972599 · Received January 18, 2011

    Report

    Report Number
    2086211-2010-00127
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 20, 2010
    Manufacturer
    DENTSPLY GAC
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# 10-02. 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 EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL END CUTTER EJB DENTSPLY GAC 08-46-1

    Patients

    Seq Age Sex Outcome Treatment
    1 014 SENTALLOY WIRE