BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 2697221 · Received July 27, 2012

    Report

    Report Number
    1811755-2012-02887
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    June 8, 2012
    Report Date
    July 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT W/O AN EVAL OF THE DEVICE. ADD'L INFO WILL BE SUBMITTED IF THE DEVICE IS REC'D FOR EVAL.

    Description of Event or Problem · 1

    THE CORE SABER DRILL WAS SENT FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; NO CLINICAL SIGNIFICANCE WAS ATTRIBUTED TO THE DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE SUMEX DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK