BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREO

    MDR report key: 18811570 · Received February 29, 2024

    Report

    Report Number
    3004142400-2017-00073
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    March 12, 2018
    Report Date
    February 29, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MNH
    PMA / PMN Number
    K124058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. THE TWO SCREWS WERE RETURNED WITH A FRACTURE AT THE NECK OF THE SCREW HEAD. THE SCREWS WERE INSPECTED AND ALL RELEVANT DIMENSIONS WERE DETERMINED TO BE WITHIN SPECIFICATION. NO DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE. ADDITIONAL PRODUCT CODES FOR THIS DEVICE ARE KWQ, NK8, MNI, KWP, AND OSH.

    Description of Event or Problem · 0

    IMAGES TAKEN (B)(6) 2017 SHOW BREAKAGE OF TWO S2 CREO SCREWS JUST BELOW THE SCREW HEAD. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747200 CREO 8.5 X 80MM MODULAR SCREW MNH GLOBUS MEDICAL, INC. 1067.1880 CWP262MA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other