BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2101960 · Received May 18, 2011

    Report

    Report Number
    1811755-2011-01808
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVAL BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED. H4: THE DEVICE SERIAL NUMBER WAS NOT PROVIDED; WITHOUT IT THE MANUFACTURED DATE OF THE DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS CALLED IN FOR OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS REPORTED, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    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