BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRENEES CERVICAL PLATE SYSTEM

    MDR report key: 6246271 · Received January 12, 2017

    Report

    Report Number
    3004774118-2016-00115
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    UDI-DI
    10888857031159
    PMA / PMN Number
    K063544
    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 REMAINS IN THE PATIENT, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. A REVIEW OF THE X-RAY CONFIRMED THE PLATE FRACTURED THROUGH THE SCREW HOLES. REVIEW OF THE X-RAY ALSO SHOWS, THE PATIENT DOES NOT APPEAR HAVE FUSED, THEREBY PLACING MORE STRESS ON THE BOTTOM OF THE PLATE, LIKELY CONTRIBUTING TO THE FAILURE. WHILE NONE OF THE IMPLANTS WERE RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. INSITU.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BROKEN 3 LEVEL PLATE. THE PATIENT REPORTEDLY HAD A 3 LEVEL PLATE BREAK APPROXIMATELY 7 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME AS THE PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29747 PYRENEES CERVICAL PLATE SYSTEM ANTERIOR CERVICAL PLATE KWQ K2M, INC. UNKNOWN 10888857031159

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR