BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALISADE

    MDR report key: 19712682 · Received July 10, 2024

    Report

    Report Number
    2135156-2024-00009
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 10, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    NKB
    UDI-DI
    M7406705535
    PMA / PMN Number
    K172107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INSTRUMENTED LUMBAR INTERBODY FUSION WITH PLACEMENT OF PALISADE SCREWS WITHOUT INCIDENT. APPROXIMATELY 10 MONTHS POST-OPERATIVE, IT WAS OBSERVED THAT ONE OF THE SCREWS WAS BROKEN. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE ALL FOUR SCREWS IN THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351950 PALISADE THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINEOLOGY INC. M7406705535

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention