BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 6025392 · Received October 13, 2016

    Report

    Report Number
    3004774118-2016-00076
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K143334
    Adverse Event
    Yes
    Product Problem
    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. THE SUBJECT PRODUCT HAS BEEN RETAINED BY THE HOSPITAL. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. HOSPITAL RETAINED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS BEEN RETAINED BY THE HOSPITAL. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. HOSPITAL RETAINED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED. SINCE THE SET SCREWS WERE RETAINED BY THE HOSPITAL, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. WHILE NONE OF THE IMPLANTS WERE RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. HOSPITAL RETAINED.

    Description of Event or Problem · 1

    ON 09/12/2016 IT WAS REPORTED TO K2M, INC. THAT A SET SCREW BACK OUT OCCURRED APPROXIMATELY 1 MONTH POST-OP. PATIENT WAS REVISED ON (B)(6) 2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SET SCREW BACK OUT OCCURRED APPROXIMATELY 1 MONTH POST-OP. PATIENT WAS REVISED ON (B)(6) 2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SET SCREW BACK OUT OCCURRED APPROXIMATELY 1 MONTH POST-OP. PATIENT WAS REVISED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676728 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. EARJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2901-10001 LOT EARJ| 2901-B60500 LOT DYKH| 2911-06540 LOT ENKP| 2911-06545 LOT EMRR