BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON TABLE SYSTEM

    MDR report key: 1045991 · Received May 14, 2008

    Report

    Report Number
    2921578-2008-00013
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    March 15, 2005
    Report Date
    May 13, 2008
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EVALUATED, MDR ISSUED DUE TO PATIENT RELATED INCIDENT. ACCORDING TO HOSPITAL, DEVICE IS NOT CAUSE OF INJURY.

    Description of Event or Problem · 1

    THE CASE REPORTEDLY LASTED MORE THAN 10 HOURS, PATIENT SUED ORTHOPEDIC SURGEON AND ANESTHESIOLOGIST BECAUSE OF A BRACHIAL PLEXUS NEUROPATHY SUFFERED DURING OR AFTER THE SURGERY. NO MDR WAS FILED BY THE HOSPITAL ACCORDING TO HOSPITAL ATTORNEY. ALSO, NO ONE IS ALLEGING ANY MALFUNCTION OR NON-PERFORMANCE OF THE JACKSON TABLE. THIS CALL WAS THE FIRST NOTIFICATION WE RECEIVED OF THIS EVENT AND OUR COMPANY IS NOT NAMED IN THE SUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON TABLE SYSTEM OPERATING ROOM TABLE, PRODUCT CODE: FWY FWY MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 SURGICAL TOP