BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2935782 · Received January 30, 2013

    Report

    Report Number
    0001811755-2013-00118
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, CORROSION WAS DISCOVERED IN THE BEARINGS, SOCKETS, AND SPINDLE HOUSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRIL HEATED UP DURING USE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, BUT WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40390 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1