BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3779175 · Received April 14, 2014

    Report

    Report Number
    3779175
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    A 1.2MM GUIDE WIRE BROKE OFF DURING THE PROCEDURE IN THE PATIENTS ELBOW. AN X-RAY WAS DONE AND READ AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228315 * GUIDEWIRE LXH SYNTHES (USA) PRODUCTS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR