BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 7537788 · Received May 23, 2018

    Report

    Report Number
    3004774118-2018-00079
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 27, 2018
    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. 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 BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, 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 PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION WAS COMPLETED AS THE LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. THE CAGE AND LATERAL FIXATION WERE FOUND NOT TO BE K2M PRODUCTS. FIXATION ACROSS MULTIPLE LEVELS OF THE SPINE MAY REDUCE THE AMOUNT OF COMPOUNDING FORCES AT THE SHAFT OF THE SCREW WHICH MIGHT HAVE LED TO THIS FAILURE. HOWEVER, SINCE THE SCREW WAS NOT RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE DUE TO A FRACTURED SCREW. A FRAGMENT OF THE SCREW REMAINS IN THE PATIENT. REVISION SURGERY TOOK PLACE (B)(6) 2018.

    Description of Event or Problem · 1

    ON 04.27.2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE DUE TO A FRACTURED SCREW. A FRAGMENT OF THE SCREW REMAINS IN THE PATIENT. REVISION SURGERY TOOK PLACE (B)(6) 2018.

    Description of Event or Problem · 1

    ON 04.27.2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE DUE TO A FRACTURED SCREW. A FRAGMENT OF THE SCREW REMAINS IN THE PATIENT. REVISION SURGERY TOOK PLACE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379426 MESA SPINAL SYSTEM PEDICLE SCREW SPINAL FIXATION NKB K2M INC. BDTW

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention