BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREXO PLUS

    MDR report key: 18536150 · Received January 17, 2024

    Report

    Report Number
    MW5150483
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 11, 2023
    Report Date
    January 12, 2024
    Manufacturer
    TREXO ROBOTICS HOLDINGS INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE PATIENT'S THERAPY SESSION AT CLINIC, THE CHILD (WC) WALKED IN THEIR TREXO PLUS DEVICE FOR THE SECOND TIME, AS PART OF THEIR REHABILITATIVE ACTIVITIES. UPON RETURNING HOME MOM NOTICED THE FRACTURE WHICH WAS LATER CONFIRMED ON X-RAY. AFTER HEARING OF THE INCIDENT, COMPANY REPRESENTATIVE WENT TO INVESTIGATE THE DEVICE AT THE CLINIC ON (B)(6) 2023 AT 12:50PM. HE FOUND EVIDENCE OF USER ERROR ON THE DEVICE ITSELF AS A RESULT OF CLINIC SUPERVISORS FAILING TO COMPLY WITH THE TREXO PLUS USER MANUAL, AND/OR TRAINING PROVIDED BY THE TREXO CUSTOMER SUCCESS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332653 TREXO PLUS SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK TREXO ROBOTICS HOLDINGS INC. A0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention