BEUDAMED
    FDA Adverse Event Summary report: N

    6310 OVATION TABLE

    MDR report key: 2240573 · Received August 24, 2011

    Report

    Report Number
    2921578-2011-00023
    Date Received
    August 24, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNK REASON OF FAILURE, REQUEST TO CUSTOMER FOR RETURN FOR EVAL.

    Description of Event or Problem · 1

    DURING A FEMUR FRACTURE CASE, THE OPERATIVE LEG WAS IN TRACTION. DURING MANIPULATION OF THE LEG AND DEVICE, THE TRACTION UNIT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6310 OVATION TABLE OPERATING ROOM TABLE JEA MIZUHO OSI 6310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other