BEUDAMED
    FDA Adverse Event Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2803151 · Received October 17, 2012

    Report

    Report Number
    1811755-2012-03827
    Date Received
    October 17, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 4, 2012
    Manufacturer
    STRYKER INSTURMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE DEVICE.

    Description of Event or Problem · 1

    A MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR EVALUATION BECAUSE A MICROAIRE BUR WAS STUCK IN IT. HOWEVER, DURING QUALITY TESTING, SEVERE WOBBLING WAS NOTED. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTURMENTS KALAMAZOO 12101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK