BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2043133 · Received March 15, 2011

    Report

    Report Number
    1831750-2011-02497
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE RAIL ASSEMBLY WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FNL STRYKER MEDICAL UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1