BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2132357 · Received June 13, 2011

    Report

    Report Number
    1811755-2011-02153
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS SENT FOR ANALYSIS BECAUSE METAL FLAKES WERE COMING OUT OF THE DEVICE DURING A PROCEDURE. FLAKES WERE NOTED AT THE SURGICAL SITE BUT WERE SUCCESSFULLY CLEANED OUT. NO FURTHER MEDICAL TREATMENT WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THIS EVENT. A REPLACEMENT DEVICE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK