BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOKOMATPRO

    MDR report key: 22540369 · Received July 18, 2025

    Report

    Report Number
    3003781275-2025-00001
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    November 1, 2023
    Report Date
    July 18, 2025
    Manufacturer
    HOCOMA AG
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRAINING WAS PERFORMED DESPITE CONTRAINDICATION (OSTEOPENIA OR OSTEOPOROSIS). THE ADVERSE EVENT HAPPENED 1.5 YEARS AGO, BUT WAS REPORTED TO US ONLY RECENTLY.

    Description of Event or Problem · 0

    DURING THE THIRD TRAINING THE PATIENT STARTED TO SHOUT AND WAS TAKEN OUT OF THE LOKOMAT. AFTER THE INCIDENT THE PATIENT WAS DIAGNOSED WITH A BONE FISSURE IN HIS LEFT FEMUR. THE PATIENT IS KNOWN TO SUFFER FROM LOW BONE DENSITY. THE EVENT WAS REPORTED TO US LATER THAN 1.5 YRS AFTER THE INCIDENT DURING A ROUTINE INTERVIEW WITH OUR CLINICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401014 LOKOMATPRO POWERED EXERCISER BXB HOCOMA AG LOKOMATPRO L6.2 FREED KOMBI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Hospitalization