BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILEAP LOWER EXTREMITY ANATOMIC PLATING SYSTEM

    MDR report key: 23260096 · Received October 9, 2025

    Report

    Report Number
    MW5177169
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 7, 2025
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOCKING SCREW FAILED TO ENGAGE IN AT LEAST ONE OF THE DISTAL HOLES OF THE PLATE DURING ATTEMPTED FIXATION. THE LOCKING MECHANISM DID NOT SEAT OR THREAD PROPERLY INTO THE PLATE, CONSISTENT WITH PRIOR REPORTED ISSUES. THE SCREW WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303576 TRILEAP LOWER EXTREMITY ANATOMIC PLATING SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female