BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUKON OCT SPINAL SYSTEM

    MDR report key: 7590571 · Received June 12, 2018

    Report

    Report Number
    3004774118-2018-00074
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    June 14, 2018
    Report Date
    May 17, 2018
    Manufacturer
    K2M INC.
    Product Code
    KWP
    PMA / PMN Number
    K171444
    Adverse Event
    Yes
    Product Problem
    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. THE SUBJECT PRODUCT WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION, AND A THOROUGH INVESTIGATION WAS COMPLETED. ALL RECORDS REVEALED THAT ALL PRODUCT(S) LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. THE SHAFT OF THE POLYAXIAL SCREW WAS BROKEN IMMEDIATELY DISTAL TO THE THIRD THREAD. ANALYSIS OF THE FRACTURE FACE SUGGESTS THAT THE SCREW FAILED IN FATIGUE. THE HEAD ASSEMBLY WAS INTACT AND EXHIBITED NO VISUAL DISCREPANCIES. EVALUATION INDICATES THAT DYNAMIC MOTION IN THE CONSTRUCT MAY HAVE RESULTED IN THE FAILURE OF THE SCREW.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BROKEN SCREW AND SET SCREW BACK-OUT APPROXIMATELY TWO MONTHS POST-OPERATIVELY. (RELATED TO 3004774118-2018-00075).

    Description of Event or Problem · 1

    ON (B)(4) 2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BROKEN SCREW AND SET SCREW BACK-OUT APPROXIMATELY TWO MONTHS POST-OPERATIVELY. PATIENT WAS REVISED ON (B)(6) 2018. (RELATED TO 3004774118-2018-00075).

    Description of Event or Problem · 1

    ON (B)(4) 2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BROKEN SCREW AND SET SCREW BACK-OUT APPROXIMATELY TWO MONTHS POST-OPERATIVELY. PATIENT WAS REVISED ON (B)(6) 2018. (RELATED TO 3004774118-2018-00075).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434854 YUKON OCT SPINAL SYSTEM SPINAL FIXATION SYSTEM KWP K2M INC. FTGG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7601-10001 LOT UNKNOWN