BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCENT TI-BOND

    MDR report key: 4324833 · Received December 4, 2014

    Report

    Report Number
    3004893332-2014-00005
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K110632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PART OF THE CAGE BROKE OFF DURING INSERTION. THE REST OF THE CAGE IS IN THE PATIENT PER SURGEON'S OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784842 LUCENT TI-BOND INTERVERTEBRAL BODY FUSION DEVICE MAX SPINAL ELEMENTS, INC. 120803

    Patients

    Seq Age Sex Outcome Treatment
    1