BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCENT

    MDR report key: 3181365 · Received June 6, 2013

    Report

    Report Number
    3181365
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON INSERTING THE LUCENT CAGE NOTED THAT IT HAD BROKEN INSIDE OF THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT SIDE LAMINECTOMY, APPLICATION OF INTERVERTEBRAL BODY DEVICE CAGE, ARTHRODESIS AND AUTOGRAFT MORESLIZED AND ALLOGRAFT MORSELIZED DEMINERALIZED BONE MATRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251851 LUCENT INTERVERTEBRAL FUSION DEVICE MAX SPINAL ELEMENTS, INC 12MM X 27MM X 27MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR