BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA ORTHOPEDIC SURGERY TABLE

    MDR report key: 4387174 · Received December 31, 2014

    Report

    Report Number
    MW5039955
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    December 29, 2014
    Manufacturer
    MIZUNO OSI
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOOT AND LOWER EXTREMITY FELL FROM POSITIONER APPROX 1 FOOT. FASTENER HOLDING EXTREMITY LOOSENED AND EXTREMITY FELL. THE SURGERY BEING PERFORMED: TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862852 HANA ORTHOPEDIC SURGERY TABLE LOWER EXTREMITY FASTENER JEB MIZUNO OSI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR