BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK

    MDR report key: 4645875 · Received March 30, 2015

    Report

    Report Number
    3007615665-2014-00001
    Event Type
    Injury
    Date Received
    March 30, 2015
    Date of Event
    December 9, 2013
    Report Date
    January 12, 2014
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    PMA / PMN Number
    K131798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) (PT AT (B)(6)) REPORTED THAT MW-2014-01 EMAILED (B)(6) ON (B)(6) 2014 THAT SHE SUFFERED A FRACTURE OF HER TIBIA AND FIBULA JUST ABOVE THE RIGHT ANKLE. MW-2014-01 SAYS THE FRACTURE OCCURRED DURING HER REWALK SESSION ON (B)(6) 2014. (B)(6) FEELS THE FRACTURE MAY HAVE OCCURRED AFTER ADJUSTMENTS WERE MADE TO SHORTEN THE LENGTH OF BOTH THE UPPER AND LOWER SEGMENTS ON THE DEVICE CAUSING THE KNEES TO FLEX WHEN COMING FROM A SIT TO STAND. A SIT TO STAND WAS PERFORMED TWICE BEFORE THE LOWER SEGMENTS WERE LENGTHENED. MW-2014-01 SAID SHE NOTICED HER RIGHT ANKLE AREA WAS NOT LOOKING RIGHT THE EVENING OF (B)(6) 2014. ON THE MORNING OF (B)(6) 2014 MW-2014-01 SAID THE RIGHT ANKLE AREA STILL DID NOT APPEAR RIGHT AND WENT TO THE ER AND WAS DIAGNOSED WITH A FRACTURE AND PLACED IN A CAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209070 REWALK POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. REHABILITATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention