BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRENEES CERVICAL PLATE SYSTEM

    MDR report key: 7076908 · Received December 1, 2017

    Report

    Report Number
    3004774118-2017-00198
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 16, 2017
    Report Date
    November 16, 2017
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K153526
    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 WAS COMPLETED AS THE LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. STRIPPED OR DAMAGED TI-FIX FEATURES OF THE SCREW DURING OR PRIOR TO INSTALLATION COULD CONTRIBUTE TO AN IMPROPER SCREW LOCK BUT SINCE THE SCREW REMAINS IN THE PATIENT, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WILL NOT BE 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) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SCREW BACK-OUT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SCREW BACK-OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856397 PYRENEES CERVICAL PLATE SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ K2M, INC. FCPA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR