BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSOM ANTERIOR CERVICAL PLATE

    MDR report key: 6386269 · Received March 7, 2017

    Report

    Report Number
    3008853203-2017-00002
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    September 1, 2016
    Report Date
    February 15, 2017
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K142060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    SURGERY WAS A C4-C7 ACDF AND A PARTIAL CORPECTOMY ON (B)(6) 2016. CERVICAL PLATE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167016 TRANSOM ANTERIOR CERVICAL PLATE APPLIANCE, FIXATION, SPINAL, INTERVERTEBRAL BODY, PRODUCT CODE :KWQ KWQ NEUROSTRUCTURES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR