BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE NUVASIVE

    MDR report key: 2481374 · Received March 2, 2012

    Report

    Report Number
    MW5024516
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 24, 2012
    Manufacturer
    NUVASIVE INC
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FLEXIBLE GUIDEWIRE BEING USED IN PERCUTANEOUS SPINE SURGERY BECAME KINKED DISTAL TO THE PEDICLE SCREW. WHEN IT WAS BEING REMOVED, IT BROKE OFF LEAVING SEVERAL MILLIMETERS BEYOND THE ANTERIOR SURFACE OF L4 NEAR THE COMMON ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE NUVASIVE GUIDEWIRE NKB NUVASIVE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening