BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANA TABLE

    MDR report key: 7600592 · Received June 13, 2018

    Report

    Report Number
    MW5077846
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING ANTERIOR HIP REPLACEMENT SURGERY AND THE NON OPERATIVE LEG FELL WHILE STILL IN THE LEG TABLE SUPPORT. THE DR DETERMINED THAT THE PT WAS NOT HARMED. MIZUHO OSI REPLACED THE PRESSURE ARM ASSEMBLY THAT WAS DAMAGED FROM THE LOCKING HANDLE EXCEEDING THE 2:00 POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439956 HANA TABLE SURGICAL TABLE FQO MIZUHO ORTHOPEDIC SYSTEMS INC. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention