BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 6101514 · Received November 15, 2016

    Report

    Report Number
    3004774118-2016-00096
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 16, 2016
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K133944
    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 SCREW WAS DISPOSED OF AT THE HOSPITAL, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. THE DAMAGE TO THE INNER COLLET OF THE SCREW IS CONSISTENT WITH MISUSE. THE INNER COLLET CAN BEND INWARD AND SHEAR IF NOT PROPERLY SUPPORTED. WHILE THE IMPLANT WAS NOT RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. HOSPITAL DISPOSED OF DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A SURGERY TOOK PLACE ON (B)(6) 2016 IN WHICH THE INNER COLLET OF A MESA SCREW SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752414 MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR 5401-84500H LOT UNKNOWN| 5416-F04730-SG LOT UNKNOWN