BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 6789695 · Received August 11, 2017

    Report

    Report Number
    3004774118-2017-00100
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    July 17, 2017
    Report Date
    July 13, 2017
    Manufacturer
    K2M, INC.
    Product Code
    MNI
    PMA / PMN Number
    K133944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. K2M ENGINEERING MADE AN IN-PERSON VISIT TO THE SURGEON TO DISCUSS THE EVENT AND FINAL TIGHTEN DRIVER OPTIONS RELATED TO HIS TECHNIQUE. FINAL TIGHTENING TECHNIQUE OR OTHER TRAUMA COULD HAVE CONTRIBUTED TO THE EVENT BUT A SINGLE CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SET SCREW BACK-OUT APPROXIMATELY 4 MONTHS POST-OP. PATIENT WAS REVISED (B)(6) 2017.

    Description of Event or Problem · 1

    ON 7.13.2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SET SCREW BACK-OUT APPROXIMATELY 4 MONTHS POST-OP. PATIENT WAS REVISED (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568279 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention