BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST ® SPINAL SYSTEM

    MDR report key: 8169877 · Received December 17, 2018

    Report

    Report Number
    3004774118-2018-00181
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 22, 2018
    Report Date
    November 22, 2018
    Manufacturer
    K2M. INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    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 INSTRUMENT WAS RETURNED, VISUALLY AND FUNCTIONALLY INSPECTED. UPON REVIEW OF THE PART, IT WAS OBSERVED THAT THE TIP WAS SHEARED IN A CLOCKWISE PATTERN DEFORMITY. THE SHEAR FACE IS SMOOTH AND SHINY, WHICH IS SUGGESTIVE OF TORQUE OVERLOADING AT THE EVENT SITE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT THE TIP OF THE CANNULATED SCREW INSERTER BROKE INTRA-OPERATIVELY. THE BROKEN TIP OF THE MODULAR SCREW INSERTER REMAINS IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS BEEN RETURNED FOR EVALUATION. 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) 2018 IT WAS REPORTED TO K2M, INC. THAT THE TIP OF THE CANNULATED SCREW INSERTER BROKE INTRA-OPERATIVELY, THE BROKEN TIP OF THE MODULAR SCREW INSERTER REMAINS IN THE PATIENT CONFINED TO THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009612 EVEREST ® SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH K2M. INC CTWM005

    Patients

    Seq Age Sex Outcome Treatment
    1