BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 7643233 · Received June 27, 2018

    Report

    Report Number
    3004774118-2018-00097
    Event Type
    Death
    Date Received
    June 27, 2018
    Date of Event
    June 19, 2018
    Report Date
    June 21, 2018
    Manufacturer
    K2M INC.
    Product Code
    NKB
    PMA / PMN Number
    K151727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. BASED ON THE REPORT FROM THE DISTRIBUTOR, A MAZOR ROBOTICS SYSTEM WAS USED TO IMPLANT AN EVEREST XT SCREW. THE PART IS NOT AVAILABLE FOR PHYSICAL EVALUATION. IT WAS DETERMINED THAT THE INCIDENT WAS NOT RELATED TO A MALFUNCTION OR FAILURE OF ANY K2M DEVICE. THE MANUFACTURING LOT NUMBER COULD NOT BE CONFIRMED.

    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) 2018 IT WAS REPORTED TO K2M, INC. THAT A THE PATIENT HAD A SIGNIFICANT CHANGE IN MEDICAL CONDITION INTRA-OPERATIVELY WHILE THE SURGEON WAS USING A K2M DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A THE PATIENT HAD A SIGNIFICANT CHANGE IN MEDICAL CONDITION INTRA-OPERATIVELY WHILE THE SURGEON WAS USING A K2M DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485933 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death