BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2231360 · Received July 18, 2011

    Report

    Report Number
    1831750-2011-07185
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: SPINDLE SPRING SPACER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAILS ARE NOT LOCKING INTO PLACE. CUSTOMER COULD NOT DETERMINE IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM204 M-SERIES W/BIG WHEEL NONE FPO STRYKER MEDICAL 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1