BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 3087038 · Received April 26, 2013

    Report

    Report Number
    2032593-2013-00026
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER NOTED, "WE HAVE A CASE DONE IN MILITARY HOSPITAL WHERE THE SCREW HEAD DISPLACED FROM ITS PEDICULAR HEAD AFTER LESS THAN 2 MONTHS. AT FIXATION, THE SCREW WAS IN POSITION. BUT AFTER ABOUT 2 MONTHS IT CAME OUT FROM ITS HEAD. THE SURGEON SUSPECTS THAT IT MAY HAVE COME OUT EARLIER. THE SURGEON SUSPECTS THAT THE DISPLACEMENT FROM THE HEAD MEANS ITS POLY AXIALITY AND THE PRESSURE LOADING CAPACITY IS NOT GOOD AND WILL BE DIFFICULT TO HANDLE IN SCOLIOSIS." ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181642 NONE MNI SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1