BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 7385479 · Received March 30, 2018

    Report

    Report Number
    3007615665-2018-00002
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    October 23, 2017
    Report Date
    March 29, 2018
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    UDI-DI
    00861803000303
    PMA / PMN Number
    K160987
    Removal / Correction Number
    Z-0944-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HE INCIDENT MAY HAVE HAPPENED DURING TRAINING. THE FRACTURES ARE ABOVE THE POSITION OF THE FRONT KNEE BRACKET (FKB) AND BELOW THE KNEE. ALSO, THERE IS A PRESSURE POINT IN THE HEIGHT OF THE SACROILIAC ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230272 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL 00861803000303

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention