BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1953111 · Received January 7, 2011

    Report

    Report Number
    1030489-2011-00024
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K042922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A C4-C5 ANTERIOR CERVICAL DISKECTOMY AND FUSION WITH AN INTERBODY IMPLANT, ANTERIOR CERVICAL PLATING, MICRODISSECTION, INTRAOPERATIVE FLUOROSCOPY, REMOVAL OF OLD ARTIFICIAL DISK AND INTEROPERATIVE MONITORING WITH BASELINE EMGS AND CONTINUOUS EMG MONITORING THROUGHOUT THE CASE, AS WELL AS BILATERAL UPPER AND LOWER EXTREMITY MOTOR EVOKED POTENTIALS AND SOMATOSENSORY EVOKED POTENTIALS. THE WOUND WAS COPIOUSLY IRRIGATED WITH BACITRACIN SOLUTION. NO ACTIVE BLEEDING IDENTIFIED. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH AN INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR CORNERSTONE INTERBODY DEVICE