BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2702392 · Received August 9, 2012

    Report

    Report Number
    1811755-2012-03051
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE ALTERNATE DEVICE WITHOUT ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK