BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2896518 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04114
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 24, 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

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITION INFO IS OBTAINED AND REQUIRES REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES, AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK