BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELOS® INTRAMEDULLARY NAILING SYSTEM

    MDR report key: 23448171 · Received November 3, 2025

    Report

    Report Number
    3010502940-2025-00001
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 2, 2025
    Manufacturer
    INTRAUMA S.P.A.
    Product Code
    HSB
    UDI-DI
    08056693001840
    PMA / PMN Number
    K201147
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INSTRUMENT BREAKAGE OCCURRED DURING CEPHALIC SCREW UNSCREWING. THE RESULTING FRAGMENTS (2 PIECES) WERE REMOVED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054307 ELOS® INTRAMEDULLARY NAILING SYSTEM CEPHALIC SCREW WRENCH/COMPRESSOR HSB INTRAUMA S.P.A. E215211 08056693001840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown