BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 20464787 · Received October 16, 2024

    Report

    Report Number
    3013450937-2024-00319
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B278FB1715203M0
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED. BASED ON THE REVIEW OF KNOWN DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE DEVICE FRACTURE WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY S. STEINERT, AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE ELOS CANAL FILLING SEGMENTAL STEM THAT WAS INSERTED INTO THE PATIENT'S FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558162 ELEOS LIMB SALVAGE SYSTEM CANAL FILLING SEGMENTAL STEM KRO ONKOS SURGICAL 89956 B278FB1715203M0

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention