BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C GUIDED ANGLE AWL

    MDR report key: 6926112 · Received October 7, 2017

    Report

    Report Number
    3005031160-2017-00160
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Report Date
    October 6, 2017
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AWL HAS NOT BEEN RECEIVED FOR EVALUATION. ANSWERS TO QUESTIONS ABOUT THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED EITHER.

    Description of Event or Problem · 1

    THE TIP OF THE AWL WAS BROKEN DURING A CASE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705589 IRIX-C GUIDED ANGLE AWL AWL HWJ X-SPINE SYSTEMS, INC. T066-0205 EM12M005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other