BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2213846 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02819
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS ANTICIPATED, BUT HAS NOT YET BEGUN. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE MFR. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    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