BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2101973 · Received May 18, 2011

    Report

    Report Number
    1811755-2011-01794
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 19, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE. FAILURE ANALYSIS IS IN PROGRESS.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK