BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI

    MDR report key: 3875037 · Received June 16, 2014

    Report

    Report Number
    3004774118-2014-00022
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 16, 2014
    Manufacturer
    K2M, INC.
    Product Code
    MNH
    PMA / PMN Number
    K042635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEDICLE SCREW WAS REMOVED AND REPOSITIONED, RATHER THAN BEING REPLACED HOWEVER, THE SET SCREW (CAT# 101-10001) AT L4 WAS REPLACED. THE SURGEON BELIEVES THE MOST LIKELY CAUSE OF THE SCREW CUTTING OUT LATERALLY WAS POOR BONE QUALITY AS THE PATIENT HAD RATHER OSTEOPOROTIC BONE. IT APPEARED ON CT THAT THERE WAS A FAINT TRACT IN THE PEDICLE AND VERTEBRAL BODY, SHOWING WHERE THE SCREWS ORIGINAL PATH HAD BEEN BUT, THE DEFINITE CAUSE OF THE SCREW MOVING IS UNKNOWN. THE REP INDICATED THAT THE SURGEON FELT HE HAD GOOD ANGULATION AND PURCHASE DURING SCREW REPOSITIONING. DURING THE RE-OPERATION, THE SURGEON DECIDED TO REMOVE THE TIP OF THE TORQUE WRENCH WHICH HAD BECOME LODGED IN THE L5 SCREW DURING THE INITIAL SURGERY. THE SURGEON LOOSENED THE SET SCREW AND REMOVAL OF THE TIP WAS PERFORMED WITH A 9 FR DIAMETER SUCTION SET AT THE HIGHEST LEVEL. THE SURGEON REPLACED THE L5 SET SCREW AS WELL. THE SURGEON INDICATED THAT THE TIP WAS VERY FIRMLY EMBEDDED IN THE SCREW AND WAS NOT CAUSING ANY PROBLEMS HOWEVER, HE THOUGHT TO REMOVE IT AS A PRECAUTION. THE TIP IN THE L5 SCREW HAD NO BEARING WHATSOEVER ON THE L4 SCREW THAT LOOSENED FROM THE BONE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PAIN AND NERVE IRRITATION TWO DAYS POST-OPERATIVELY. AS A PRECAUTION, THE SURGEON PERFORMED A CT AND NOTICED THE L4 DENALI SCREW HAD PULLED OUT LATERALLY.THE PATIENT WAS RE-OPERATED ON FOUR DAYS POST-OP AND THE SCREW WAS RE-POSITIONED AND RE-IMPLANTED. THE LEG PAIN IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353408 DENALI PEDICLE SCREW MNH K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention