BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARINER PEDICLE SCREW SYSTEM

    MDR report key: 11924504 · Received June 2, 2021

    Report

    Report Number
    3012120772-2021-00045
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 2, 2021
    Manufacturer
    SEASPINE INC.
    Product Code
    NKB
    UDI-DI
    10889981155100
    PMA / PMN Number
    K173882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SEASPINE WAS MADE AWARE OF THIS EVENT ON 3 MAY 2021. TO DATE, NO EXPLANTS OR INSTRUMENTATION HAVE BEEN MADE AVAILABLE FOR ANALYSIS, AND NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION OR TREATMENT PLAN HAS BEEN COMMUNICATED TO SEASPINE. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS: LOOSENING OF SPINAL FIXATION IMPLANTS MAY OCCUR DUE TO, LATENT INFECTION, AND/OR PREMATURE LOADING, POSSIBLY RESULTING IN BONE EROSION, MIGRATION OR PAIN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM IN (B)(6) 2020. THE SURGEON IDENTIFIED THE SET SCREWS ON THE ILIAC BOLTS OF THE CONSTRUCT HAD BECOME LOOSE, AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. SEASPINE WAS MADE AWARE OF THIS EVENT ON 3 MAY 2021. TO DATE, NO EXPLANTS OR INSTRUMENTATION HAVE BEEN MADE AVAILABLE FOR ANALYSIS, AND NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION OR TREATMENT PLAN HAS BEEN COMMUNICATED TO SEASPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818657 MARINER PEDICLE SCREW SYSTEM SET SCREW NKB SEASPINE INC. 41-1010 10889981155100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention