BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOCOMA

    MDR report key: 25318307 · Received May 28, 2026

    Report

    Report Number
    3003781275-2026-00001
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 22, 2026
    Report Date
    May 28, 2026
    Manufacturer
    HOCOMA AG
    Product Code
    BXB
    UDI-DI
    07640174660155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOOSING A SHOE IS HARDLY POSSIBLE WHEN USER STICKS TO THE BEST PRACTICE FOR THIS DEVICE. IT LEADS US TO THE CONCLUSION THAT THE FOOTLIFTERS OF THE DEVICE WERE NOT USED DESPITE BEING RECOMMENDED BEST PRACTICE BY THE MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT LOOSES SHOE AND DRAGS TOES ON TREADMILL OF ROBOTIC REHABILITATION DEVICE. LOKOMAT WAS STOPPED BY THERAPIST AND TRAINING CONTINUED. X-RAY ON (B)(6) 26. REVEALED DISTAL FRACTURES OF TIBIA AND FIBULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83475 HOCOMA LOKOMATPRO L6.2 FREED KOMBI BXB HOCOMA AG 07640174660155

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization