BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO

    MDR report key: 25246722 · Received May 21, 2026

    Report

    Report Number
    2031966-2026-00074
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 21, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517167729
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED A COMPLAINT REPORTING THAT A FIXATION PIN (7890029) WAS BROKEN DURING SURGERY AND REMAINS IN THE PATIENT. ACCORDING TO THE REP THE FIXATION PIN WAS INSERTED INTO THE VERTEBRAL BODY AND THE TIP FRACTURED OFF INSIDE THE VERTEBRAL BODY. RETRIEVAL OF THE BROKEN TIP WAS IMPOSSIBLE AND THEREFORE IT HAD TO BE LEFT IN THE PATIENT. THE REPRESENTATIVE WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION OR PHOTOGRAPHS OF THE REPORTED EVENT. THE FRACTURED REMAINS OF THE FIXATION PIN WERE NOT RETURNED TO PD. THEREFORE, THE LOT NUMBER IS UNKNOWN, AND THE PRODUCT WAS NOT AVAILABLE TO BE REVIEWED BY PD. THE PRODUCT WAS NOT ABLE TO BE EVALUATED AS IT REMAINS IN THE PATIENT AND THE OTHER HALF OF THE FRACTURED PIN WAS NOT RETURNED. BASED ON THE REPORTED INFORMATION, A POSSIBLE ROOT CAUSE OF THE ISSUE IS IMPROPER TECHNIQUE OR EXCESSIVE FORCE. LABELING, MANUFACTURING, AND RISK REVIEWS WERE COMPLETED WITH NO DEFICIENCIES, DISCREPANCIES OR ADVERSE TRENDS NOTED. COMPLAINT MONITORING WILL CONTINUE AND ADDITIONAL ACTION WILL BE TAKEN IN THE EVENT THAT AN ADVERSE TREND IS IDENTIFIED. NO ADDITIONAL ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIXATION PIN BROKE DURING SURGERY IN PATIENT¿S VERTEBRAL BODY. RETRIEVAL OF THE BROKEN PORTION WAS IMPOSSIBLE AND HAD TO BE LEFT IN PATIENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524303 HALO INTERNAL SPINAL FIXATION PROCEDURE KIT, SINGLE-USE LXH NUVASIVE, INC. 7890029 00887517167729

    Patients

    Seq Age Sex Outcome Treatment
    1