BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWPORT MIS CAP

    MDR report key: 3931431 · Received June 27, 2014

    Report

    Report Number
    2032593-2014-00031
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPLANTED A FRACTURED NEWPORT SET SCREW. THE SET SCREW WAS NO LONGER ENGAGED WITH THE SCREW TULIP AND WAS FREE BENEATH THE FASCIA. THE ORIGINAL 2 LEVEL CONSTRUCT WAS LEFT INTACT WITHOUT A SET SCREW AT L5 ON THE RIGHT. THE INITIAL IMPLANT SURGERY WAS ON (B)(6) 2014. THE WELD ON THE OUTER CASING OF THE SET SCREW FRACTURED. ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER. THE REPORTED ISSUE WAS DISCOVERED DURING A ROUTINE POST-OPERATIVE X-RAY TAKEN APPROXIMATELY 3 WEEKS AFTER THE IMPLANT SURGERY. THE FACILITY WOULD NOT RELEASE THE DEVICE; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. IMAGES OF THE BROKEN SET SCREW AND AN X-RAY WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375975 NEWPORT MIS CAP NEWPORT NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention