BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6850 PROFX

    MDR report key: 2243722 · Received July 29, 2011

    Report

    Report Number
    2921578-2011-00018
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MIZUHO OSI
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION BEGUN. WILL ADVISE UPON COMPLETION ((B)(4) 2011).

    Description of Event or Problem · 1

    THE GLUE HOLDING THE PUSH ROD ON THE PROFX SPAR FAILED AN THE FOOT END FITTING BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6850 PROFX ORTHOPEDIC OPERATING ROOM TABLE JEB MIZUHO OSI 6850

    Patients

    Seq Age Sex Outcome Treatment
    1