BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROENT

    MDR report key: 23053304 · Received September 15, 2025

    Report

    Report Number
    2031966-2025-00124
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 11, 2025
    Report Date
    March 5, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    UDI-DI
    00887517283429
    PMA / PMN Number
    K141665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF INVESTIGATION, THE BROKEN COROENT LARGE MP SPACER (P/N 6080828) HAS NOT BEEN RETURNED. NO OPERATIVE NOTES, OR PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE CLINICAL SPECIALIST REPORTED THAT THE PEEK CAGE BROKE APART WHEN INSERTED INTO THE PATIENT. IT WAS SUCCESSFULLY REMOVED FROM THE INSERTER AND THEN REMOVED BY THE SURGEON IN PIECES. THE SURGEON THEN INSERTED A NEW CAGE AND IS CONFIDENT THAT ALL OF THE BROKEN CAGE HAS BEEN REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT. BECAUSE THE PART WAS NOT RETURNED FOR EVALUATION, THE COMPLAINT WAS MARKED NON-VERIFIABLE. LABELING REVIEW: "...WARNINGS, CAUTIONS AND PRECAUTIONS THE SUBJECT DEVICE IS INTENDED FOR USE ONLY AS INDICATED. THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. 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." "...ALL IMPLANTS SHOULD BE USED ONLY WITH THE APPROPRIATELY DESIGNATED INSTRUMENT". "...NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE." "...DEVICES SHOULD BE INSPECTED FOR DAMAGE PRIOR TO IMPLANTATION. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." DHR REVIEW: A DHR REVIEW WAS UNABLE TO BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED IN THE EVENT EVALUATION REPORT FOR THIS COMPLAINT. RISK REVIEW: REVIEW OF THE ASSOCIATED RISK DOCUMENTATION DETERMINED THE SEVERITY AND RATE OF OCCURRENCE DOCUMENTED IN THIS REPORTED EVENT DO NOT EXCEED THE POST-MITIGATED SEVERITY, AND FAILURE MODE PROBABILITY, ESTIMATED IN THE RISK MANAGEMENT FILE. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. CONCLUSION: LABELING, COMPLAINT HISTORY, AND RISK REVIEWS WERE COMPLETED WITH NO DEFICIENCIES, DISCREPANCIES, OR ADVERSE TRENDS IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS UNAVAILABLE FOR EVALUATION AS IT REMAINS IN SITU. 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 A COROENT PEEK CAGE (8 DEGREE, 28X9X8) BROKE APART WHEN INSERTED INTO THE PATIENT. THE CAGE WAS SUCCESSFULLY REMOVED FROM THE INSERTER AND THEN REMOVED BY SURGEON IN PIECES. THE SURGEON THEN INSERTED A NEW CAGE AND IS CONFIDENT THAT ALL OF THE BROKEN CAGE HAS BEEN REMOVED FROM THE PATIENT.

    Description of Event or Problem · 0

    COROENT PEEK CAGE FRACTURED AND WAS REPLACED DURING SURGERY. THIS EVENT OCCURRED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466887 COROENT POLYMERIC SPINAL INTERBODY FUSION CAGE MAX NUVASIVE, INC. 6080828 00887517283429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention