BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNUFLEX GUIDE WIRE

    MDR report key: 23499 · Received July 18, 1995

    Report

    Report Number
    MW1006515
    Event Type
    Malfunction
    Date Received
    July 18, 1995
    Date of Event
    June 30, 1995
    Report Date
    July 6, 1995
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDE WIRE REMAINED IN CANNULATED SCREW, AND 2 CMS BROKE OFF. GUIDE WIRE REMAINED IN PT, LODGED UNDER THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNUFLEX GUIDE WIRE GUIDE WIRE HXI ACUFEX MICROSURGICAL, INC. 045 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR