BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2231257 · Received July 25, 2011

    Report

    Report Number
    1811755-2011-02669
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO SAGITTAL LEAKED AN OIL-LIKE SUBSTANCE ON TO THE BONE DURING A PROCEDURE. THE LEAKAGE WAS NOTED AT THE END OF THE PROCEDURE AND THE SUBSTANCE WAS LAVAGED OUT OF THE SURGICAL SITE. NO FURTHER TREATMENT WAS REPORTED; NO ADVERSE EVENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK