BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVENILE TUMOR SYSTEM (JTS)

    MDR report key: 19912654 · Received August 5, 2024

    Report

    Report Number
    3013450937-2024-00265
    Event Type
    Injury
    Date Received
    August 5, 2024
    Report Date
    August 5, 2024
    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

    IT WAS REPORTED THAT THE PREVIOUS JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT STANDARD SMILES ROTATING HINGE KNEE (PIN 100327) BECAME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293494 JUVENILE TUMOR SYSTEM (JTS) JTS (NON-INVASIVE) EXTENDIBLE DISTAL FEMORAL REPLACEMENT KRO ONKOS SURGICAL PIN 100327 PIN 100327

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Unknown Hospitalization