BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 8663604 · Received June 3, 2019

    Report

    Report Number
    3004774118-2019-00063
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    March 5, 2019
    Report Date
    January 29, 2020
    Manufacturer
    K2M INC.
    Product Code
    NKB
    PMA / PMN Number
    K141873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE FLUORO IMAGES PROVIDED, IT CAN ONLY BE CONFIRMED THAT ONE SET SCREW HAS LOOSENED/ DISENGAGED FROM THE TULIP. IN THE EVENT THAT A SET SCREW LOOSENS OR DISENGAGES, IT IS POSSIBLE THAT THE SET SCREW MAY HAVE BEEN UNDER TORQUED UPON INDEX SURGERY. IT IS ALSO POSSIBLE THAT THE ROD WAS NOT FULLY SEATED UPON INDEX SURGERY. EITHER OF THE LATTER SITUATIONS MAY HAVE CAUSED THE CAPTURE STRENGTH OF THE SET SCREW/ TULIP LOCKING MECHANISM TO WEAKEN UPON LOADING AND DYNAMIC MOTION OVER THE TWO-YEAR TIME PERIOD. A WEAKENED LOCKING MECHANISM COULD HAVE LED TO THE SET SCREW DISENGAGING FROM THE TULIP. THE ROD SLIPPAGE COULD HAVE RESULTED FROM THE WEAKENED CAPTURE MECHANISM. HOWEVER, AS THE PARTS WERE NOT AVAILABLE, THE SET SCREWS COULD NOT BE INSPECTED TO REACH A CONCLUSIVE ROOT CAUSE. MANUFACTURING RECORDS WERE REVIEWED, AND NO RELEVANT MANUFACTURING ISSUES WERE FOUND.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED THAT FOUR DENALI SCREWS BECAME LOOSE POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS REPORTED THAT A FOUR DENALI SCREWS BECAME LOOSE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456186 DENALI SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M INC. EYGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 101-06550 LOT EKRG| 101-06550 LOT EKRG| 101-06550 LOT EVUJ| 101-06550 LOT EVUJ| 101-A555500 LOT BUYE| 101-A555500 LOT BUYE| 101-06550 LOT EKRG| 101-06550 LOT EVUJ| 101-A555500 LOT BUYE