BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL DISTAL END CUTTER

    MDR report key: 1689291 · Received May 5, 2010

    Report

    Report Number
    2086211-2010-00059
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Report Date
    January 20, 2010
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THIS 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 WAS RETURNED AND THE TIP AND SCREW ASSEMBLY WERE REPLACED. ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A SMALL DISTAL END CUTTER SEPARATED. THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL DISTAL END CUTTER EJB GAC INTERNATIONAL 09-14-2

    Patients

    Seq Age Sex Outcome Treatment
    1