BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2200955 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02388
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERE CORROSION DAMAGE WAS NOTED WITHIN THE DEVICE.

    Description of Event or Problem · 1

    THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR ANALYSIS BECAUSE IT WAS LEAKING OIL DURING A PROCEDURE. THERE WAS NO LEAKAGE INTO THE SURGICAL SITE; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 07247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK