BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEX-D2 POSTERIOR FIXATION SYSTEM

    MDR report key: 22766514 · Received August 9, 2025

    Report

    Report Number
    3010020754-2025-00002
    Event Type
    Malfunction
    Date Received
    August 9, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 16, 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

    BONE TAPS REQUESTED BUT WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING A SURGICAL OPERATION PROCEDURE INVOLVING SPINAL FIXATION OF THE VERTEBRA T8 AND T9, COMPLICATIONS AROSE WITH THE INSTRUMENTATION. WHILE TAPPING THE VERTEBRAE, THE TIP OF THE INITIAL 4.5MM BONE TAP FRACTURED AND BECAME LODGED WITHIN THE T8 VERTEBRAL BODY. SUBSEQUENTLY, A SECOND 4.5MM BONE TAP WAS USED FOR T9, THE TIP OF THIS BONE TAP ALSO BECAME LODGED. RESULTING IN TWO SPERATE BONE TAP FRAGMENTS RETAINED WITHIN THE RESPECTIVE VERTEBRAE (T8 AND T9).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003692 NEX-D2 POSTERIOR FIXATION SYSTEM BONE TAP, MIS, 4.5MM LXH NEXT ORTHOSURGICAL CBZB005-45 002156D13 & 003288F02 00840314121103

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention