BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASCADIA INTERBODY SYSTEM

    MDR report key: 6902929 · Received September 28, 2017

    Report

    Report Number
    3004774118-2017-00149
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    June 7, 2017
    Report Date
    August 14, 2017
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    PMA / PMN Number
    K160547
    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 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. SINCE THE PRODUCT HAS NOT BEEN RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. IMPLANT POSITIONING OR CHOICE OF IMPLANT CONFIGURATION COULD HAVE CONTRIBUTED TO MIGRATION. HOWEVER, WITHOUT THE ACTUAL IMPLANT NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED. THE CATALOG NUMBER HAS NOT BEEN 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.

    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 INTERBODY SPACER HAD MIGRATED POST-OPERATIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2017 AN X-RAY WAS PROVIDED TO K2M, INC. WHICH SHOWED A POSSIBLE INTERBODY MIGRATION. NO OTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2017 AN X-RAY WAS PROVIDED TO K2M, INC. WHICH SHOWED A POSSIBLE INTERBODY MIGRATION. NO OTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682646 CASCADIA INTERBODY SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR