BEUDAMED
    FDA Adverse Event Summary report: N

    SECURE C

    MDR report key: 4101514 · Received August 29, 2014

    Report

    Report Number
    3004142400-2014-00042
    Date Received
    August 29, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWP
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION OTHER THAN A REMOVAL OF A SECURE C DEVICE HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    GLOBUS RECEIVED NOTIFICATION (B)(6) 2014 VIA A SURVEY THAT A PATIENT HAD A SECURE C IMPLANT REMOVED. GLOBUS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION SURROUNDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529064 SECURE C NONE KWP GLOBUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention