BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 2132316 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02122
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, BUT BASED ON THE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE DEVICE LEAKING COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS LEAKING. THE ACCOUNT ADVISED THAT THE PATIENT INVOLVEMENT IS UNKNOWN. ADVERSE CONSEQUENCES ARE ALSO UNKNOWN, BUT AT THIS TIME, THERE HAVE BEEN NO KNOWN ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK