BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVEREST® SPINAL SYSTEM

    MDR report key: 6985447 · Received October 27, 2017

    Report

    Report Number
    3004774118-2017-00184
    Event Type
    Death
    Date Received
    October 27, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 28, 2017
    Manufacturer
    K2M. INC
    Product Code
    NKB
    PMA / PMN Number
    K133944
    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. IT WAS REPORTED DURING A SURGERY UTILIZING THE EVEREST PEDICLE SCREW SYSTEM, THE PATIENT EXPERIENCED A CHANGE IN MEDICAL CONDITION. THE HARDWARE APPLICATION WAS STOPPED TO ATTEND TO THE MEDICAL CONDITION. THE HARDWARE APPLICATION WAS NOT COMPLETED. NO ADVERSE EVENTS INVOLVING HARDWARE WERE OBSERVED. AS REPORTED BY THE SURGEON, THIS WAS NOT A HARDWARE RELATED EVENT.

    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

    IT WAS REPORTED DURING A SURGERY UTILIZING THE EVEREST PEDICLE SCREW SYSTEM, THE PATIENT EXPERIENCED A CHANGE IN MEDICAL CONDITION. THE HARDWARE APPLICATION WAS STOPPED TO ATTEND TO THE MEDICAL CONDITION. THE HARDWARE APPLICATION WAS NOT COMPLETED. NO ADVERSE EVENTS INVOLVING HARDWARE WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGERY UTILIZING THE EVEREST PEDICLE SCREW SYSTEM, THE PATIENT EXPERIENCED A CHANGE IN MEDICAL CONDITION. THE HARDWARE APPLICATION WAS STOPPED TO ATTEND TO THE MEDICAL CONDITION. THE HARDWARE APPLICATION WAS NOT COMPLETED. NO ADVERSE EVENTS INVOLVING HARDWARE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764486 EVEREST® SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M. INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death