BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 7783635 · Received August 14, 2018

    Report

    Report Number
    3004774118-2018-00128
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 20, 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 · 0

    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. UPON REVIEW OF THE RODS, IT WAS OBSERVED THAT ONE ROD WAS BROKEN IN TWO PLACES, AND THE OTHER ROD WAS BROKEN IN ONE. ANALYSIS OF THE SHEAR FACES REVEALED THAT THE RODS FAILED FROM FATIGUE. ADDITIONAL MARKINGS ALONG THE RODS SUGGEST THAT THE ROD WAS ENGAGED WITH THE APPROPRIATE INSTRUMENTATION. THESE DEVICES ARE INDICATED TO PROVIDE TEMPORARY FIXATION IN ORDER TO FACILITATE ARTHRODESIS IN THE SPINE. FUSION AT THE SUBJECT LEVELS COULD NOT BE CONFIRMED. IT IS POSSIBLE FOR A NON-FUSION TO ALLOW FOR DYNAMIC MOTION WITHIN THE CONSTRUCT, WHICH MAY INTRODUCE COMPOUNDING STRESSES TO THE HARDWARE, CAUSING THE METAL TO FAIL IN FATIGUE.

    Description of Event or Problem · 0

    ON 7.20.2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH TWO BROKEN RODS AND A BROKEN SCREW WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2018. (RELATED TO 3004774118-2018-00131).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH TWO BROKEN RODS AND A BROKEN SCREW WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622717 DENALI SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M INC. DTUU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 801-36545M LOT DUUD| 801-36545M LOT DUUD