BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE COROENT XL INTERFIXATED SYSTEM

    MDR report key: 23350693 · Received October 21, 2025

    Report

    Report Number
    2031966-2025-00142
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 21, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    ODP
    UDI-DI
    00887517279644
    PMA / PMN Number
    K203201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    THE COROENT XL-H CUTTER FRACTURED DURING SURGERY AND REVISION REQUIRED TO REMOVE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975028 NUVASIVE COROENT XL INTERFIXATED SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR ODP GLOBUS MEDICAL, INC. 1604100 00887517279644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown