BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVENILE TUMOR SYSTEM (JTS)

    MDR report key: 23620351 · Received November 21, 2025

    Report

    Report Number
    3013450937-2025-00363
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    AN ALLEGED INFECTION WAS REPORTED INVOLVING THE IN-SITU JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT (C24-0598).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347905 JUVENILE TUMOR SYSTEM (JTS) JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT KRO ONKOS SURGICAL C24-0598 C24-0598

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Hospitalization