BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS SAG SAW

    MDR report key: 2123430 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02069
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    August 23, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TPS SAGITTAL SAW WAS SENT FOR SERVICE AND IT OVERHEATED DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK