BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEX-D2 POSTERIOR FIXATION SYSTEM

    MDR report key: 22997742 · Received September 8, 2025

    Report

    Report Number
    3010020754-2025-00003
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 5, 2024
    Report Date
    August 29, 2025
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    LXH
    UDI-DI
    00840314121103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    DURING FIXATION OF L4 AND L5 VERTABREA THE TIP OF THE BONE TAP 4.5MM PN CBZB005-45 LN 0001217C1 BROKE WHILE TAPPING L5. A SNAPPING SOUND WAS HEARD AND FRAGMENTS OF THE TIP OF THE BONE TAP BECAME LODGED INSIDE THE BONE AND COULD NOT BE REMOVED. L5 WAS SKIPPED AND INSTEAD S1 WAS USED IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068621 NEX-D2 POSTERIOR FIXATION SYSTEM BONE TAP, MIS, 4.5MM LXH NEXT ORTHOSURGICAL CBZB005-45 0001217C1 00840314121103

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention