BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM RESOLVE POLYAXIAL PEDICLE SCREW, 50MM

    MDR report key: 3170414 · Received June 7, 2013

    Report

    Report Number
    3004142400-2013-00012
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ONGOING AND WE WILL PROVIDE DETAILS OF THE INVESTIGATION WHEN ADDITIONAL INFO IS RECEIVED AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS A REVISION SURGERY HAD TAKEN PLACE AT (B)(6). THE EXPLANTED PARTS WERE RETURNED TO GLOBUS FOR EVALUATION. ONE 6.5 MM RESOLVE POLYAXIAL PEDICLE SCREW, 50 MM WAS RETURNED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253413 6.5MM RESOLVE POLYAXIAL PEDICLE SCREW, 50MM 6.5MM RESOLVE POLYAXIAL SCREW NKB GLOBUS MEDICAL, INC. 185.466 BAL090KB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention