BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS (JUVENILE TUMOR SYSTEM)

    MDR report key: 24218477 · Received January 29, 2026

    Report

    Report Number
    3013450937-2026-00061
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AN INVESTIGATION OF THE DEVICE HISTORY RECORD AND POST-MARKET SURVEILLANCE HISTORY WAS COMPLETED AND NOTHING WAS FOUND. IF ADDITIONAL INFORMATION IS OBTAINED OR IF THE DEVICE IS RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE IN THEIR TIBIAL COMPONENT. THE TIBIAL COMPONENT IN-SITU IS A DISTAL FEMORAL REPLACEMENT - REVISION TIBIAL COMPONENT (PIN 100301).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268262 JTS (JUVENILE TUMOR SYSTEM) DISTAL FEMORAL REPLACEMENT - REVISION TIBIAL COMPONENT KRO ONKOS SURGICAL PIN 100301 PIN 100301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization