BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREO

    MDR report key: 18812520 · Received February 29, 2024

    Report

    Report Number
    3004142400-2018-00010
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 19, 2018
    Report Date
    February 29, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MNH
    UDI-DI
    00889095071139
    PMA / PMN Number
    K124058
    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 DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE. IF A REVISION SURGERY IS PERFORMED AND THE IMPLANT RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED. ADDITIONAL PRODUCT CODES FOR THIS DEVICE ARE: KWQ, NKB, MNI, KWP, AND OSH.

    Description of Event or Problem · 0

    A CREO LOCKING CAP HAS DISASSOCIATED FROM THE SCREW HEAD. NO REVISION IS SCHEDULED. THE INITIAL SURGERY WAS (B)(6)2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001391 CREO CREO MIS LOCKING CAP MNH GLOBUS MEDICAL, INC. 1134.0010 00889095071139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other