BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C GUIDED ANGLE AWL

    MDR report key: 7001813 · Received November 3, 2017

    Report

    Report Number
    3005031160-2017-00161
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 2, 2017
    Report Date
    November 3, 2017
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AWL HAS NOT BEEN RECEIVED FOR EVALUATION, HOWEVER PART NUMBER AND LOT NUMBER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    THE TIP OF THE GUIDED ANGLE AWL BROKE DURING SURGERY, IT WAS ALREADY A LITTLE BENT. THERE WAS NO INJURY CAUSED TO THE PATIENT. THE STRAIGHT AWL WAS THEN USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778620 IRIX-C GUIDED ANGLE AWL AWL HWJ X-SPINE SYSTEMS, INC. T066-0205 EM14F003

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other