BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERE

    MDR report key: 6285809 · Received January 30, 2017

    Report

    Report Number
    3004142400-2016-00054
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K100788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE IMPLANT REMAINS IN THE PATIENT, NO DETERMINATIONS AS TO THE CAUSE OF THE BREAKAGE CAN BE MADE. GLOBUS WILL FILE A SUPPLEMENTAL REPORT WHEN THE REVISION SURGERY IS COMPLETED. ADDITIONAL PRODUCT CODES FOR THIS IMPLANT ARE: MNH, NKB, MNI, KWP.

    Description of Event or Problem · 1

    IT WAS REPORTED A STUDY PATIENT HAS BROKEN REVERE RODS. A REVISION WILL BE REQUIRED, BUT NO DATE HAS BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71682 REVERE REVERE ROD KWQ GLOBUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention