BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CORE

    MDR report key: 22998433 · Received September 8, 2025

    Report

    Report Number
    2031966-2025-00119
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    February 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MPQ
    UDI-DI
    00887517365811
    PMA / PMN Number
    K090176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, LO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THAT SEVERAL ATTEMPTS WERE MADE TO CONTACT THE SALES REP FOR ADDITIONAL INFORMATION; HOWEVER, THE REP WAS UNABLE TO PROVIDE FURTHER INFORMATION AS THEY ARE NO LONGER WITH THE COMPANY. NO OPERATIVE NOTES, OR PHOTOGRAPHS WERE PROVIDED FOR REVIEW. LIMITED INFORMATION IS AVAILABLE OUTSIDE OF THE REPORTED INFORMATION THAT ¿THE X-CORE FAILED TO EXPAND DURING A CASE AND ANOTHER IMPLANT WAS USED.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER CAGE, AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE DEVICE WAS REVIEWED BY PD ON 12/05/25 AND THE COMPLAINT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THAT THE GEAR TEETH ON THE X-CORE 2 TI CORE, Ø18MM 21-27MM AUTOLOCK WERE DAMAGED AND HAD WEAR NOTED ON EVERY GEAR TOOTH. WHEN CONNECTED TO AN INSERTER, THE CORE WAS UNABLE TO EXPAND OR COLLAPSE. BASED ON THE REPORTED INFORMATION, A PROBABLE CAUSE OF THIS FAILURE IS POSSIBLE EXCESSIVE FORCE OR USER TECHNIQUE, WHICH ARE NOTED PRECAUTIONS IN THE PRODUCT LABELING. REVIEW OF THE DEVICE HISTORY RECORDS NOTES NO MATERIAL NON-CONFORMANCE¿S, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. A RISK RECONCILIATION WAS PERFORMED AND CONFIRMS THAT THE TYPE AND FREQUENCY OF THIS FAILURE IS CAPTURED IN OUR LATEST RISK ANALYSIS. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. THE PRODUCT IS WITHIN THE ANTICIPATED RISK; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND WILL CONTINUE TO BE MONITORED. 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¿" LABELING, MANUFACTURING, COMPLAINT HISTORY, AND RISK REVIEWS WERE COMPLETED WITH NO DEFICIENCIES, DISCREPANCIES, OR ADVERSE TRENDS IDENTIFIED. THE DEVICE WAS DISPOSITIONED FOR SCRAP, AND THE EVENT WILL BE USED FOR TREND DATA. 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 X-CORE FAILED TO EXPAND DURING A CASE AND ANOTHER IMPLANT WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE X-CORE FAILED TO EXPAND DURING A CASE AND ANOTHER IMPLANT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068662 X-CORE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MPQ NUVASIVE, INC. 7180027A PD1006 00887517365811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention