BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CORE

    MDR report key: 23457944 · Received November 3, 2025

    Report

    Report Number
    2031966-2025-00145
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 2, 2025
    Report Date
    December 31, 2025
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    UDI-DI
    00887517424235
    PMA / PMN Number
    K090176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THAT AFTER SEVERAL ATTEMPTS ADDITIONAL INFORMATION REGARDING THIS EVENT WAS NOT ABLE TO BE OBTAINED. NO OPERATIVE NOTES, OR PHOTOGRAPHS WERE PROVIDED FOR REVIEW. LIMITED INFORMATION IS AVAILABLE OUTSIDE OF THE REPORTED INFORMATION THAT ¿THE CORE DOES NOT EXPAND; THE SURGEON REMOVED IT AND IMPLANTED ANOTHER ONE AND DISCARDED THE DEFECTIVE CORE.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER CAGE, AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE DEVICE WAS NOT RECEIVED BY MANUFACTURER, AND THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BASED ON THE REPORTED INFORMATION, A PROBABLE CAUSE OF THIS FAILURE IS EXCESSIVE FORCE OR USER TECHNIQUE, WHICH ARE NOTED PRECAUTIONS IN THE PRODUCT LABELING. LABELING REVIEW: WARNING, CAUTIONS, AND PRECAUTIONS: ¿...CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE...¿ ¿.. AVOID EXCESSIVE DISTRACTION TO DECREASE THE RISK OF OVER DISTRACTION CAUSING NEUROLOGIC INJURY¿¿ ¿.. TO HELP ENSURE PROPER INSERTER/IMPLANT ENGAGEMENT, THE INSERTER¿S-COLORED DISTAL TIP MUST FACE UP TOWARD THE LIKE-COLORED SPINNING SLEEVE OF THE IMPLANT. TO HELP ENSURE PROPER ANATOMICAL ALIGNMENT, THE ROUNDED CORNERS OF THE X-CORE SHAPE ENDCAPS MUST FACE ANTERIOR DURING IMPLANT CONSTRUCTION AND PLACEMENT...¿ PRE-OPERATIVE WARNINGS ¿...CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT¿¿ THE COMPLAINT FILE WAS EVALUATED, AND IT WAS DETERMINED THAT THE REPORT RELATES TO A NUVASIVE X-CORE 2 TI CORE, Ø16MM 18-25MM AUTOLOCK. THE REPORT INDICATES THAT THE CAGE WAS NOT EXPANDING WHEN INSERTED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORTED EVENT. LABELING, MANUFACTURING, AND RISK REVIEWS 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS UNAVAILABLE FOR EVALUATION AS IT WAS DISPOSED OF AT THE HOSPITAL. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE X-CORE 2 FAILED TO EXPAND. THE SURGEON REMOVED IT AND IMPLANTED ANOTHER ONE. THE HOSPITAL STAFF THREW AWAY THE DEFECTIVE ONE SO THERE WILL BE NO PART RETURNED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE X-CORE 2 FAILED TO EXPAND. THE SURGEON REMOVED IT AND IMPLANTED ANOTHER ONE. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709891 X-CORE VERTEBRAL BODY PROSTHESIS MQP NUVASIVE, INC. 7160025 FM1139EC 00887517424235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown