BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2

    MDR report key: 19914115 · Received August 5, 2024

    Report

    Report Number
    3010020754-2024-00004
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 5, 2024
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    LXH
    PMA / PMN Number
    K190981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION LOT RECORDS WERE REVIEWED AND THERE WERE NO ABNORMALITIES INDICATING MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS. THERE ARE NO TRENDS OR ADDITIONAL ADVERSE EVENTS FOR THIS PRODUCTION LOT. THE IMAGES OF THE REMAINDER OF THE INSTRUMENT WERE REVIEWED AND THE TIP APPEARS DEFORMED IN THE DIRECTION OF SCREW INSERTION. INVESTIGATION IS STILL ONGOING, BUT INITIAL INVESTIGATIVE RESULTS LEAD TO EXCESSIVE FORCE DURING USAGE OF THE INSTRUMENT. IF FURTHER INFORMATION IS PROVIDED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE TIP OF THE INSTRUMENT BROKE OFF DURING SURGICAL PROCEDURE. THIS INSTRUMENT TIP REMAINED IMPLANTED IN THE PEDICLE SCREW TULIP. THE SURGEON KEPT THE TIP IN THE TULIP AND TIGHTENED THE SUBSEQUENTLY IMPLANTED ROD AND SET SCREW ATOP THE TULIP-INSTRUMENT TIP CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675496 NEX-D2 SCREW HEIGHT ADJUSTER LXH NEXT ORTHOSURGICAL CBZA047-00 002149B15B

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Prefer Not To Disclose Other