BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUVASIVE LATERAL PLATE SYSTEM

    MDR report key: 983743 · Received January 16, 2008

    Report

    Report Number
    2031966-2008-00001
    Event Type
    Other
    Date Received
    January 16, 2008
    Date of Event
    December 13, 2007
    Report Date
    January 14, 2008
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K061789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS NOT KNOWN AT THIS TIME. THE DEVICE WAS NOT REMOVED AND NO ADDITIONAL EVALUATION WAS POSSIBLE. THERE IS NO ALLEGATION OF DEVICE FAILURE. NUVASIVE IS CURRENTLY INVESTIGATING WHETHER PT PHYSIOLOGY OR AN ELEMENT OF THE SURGICAL PROCEDURE MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT LABELING STATES THAT "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." IN THE EVENT THAT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PT RECEIVED AN XLIF AT L3-L4/L4-L5 IN 2007 USING THE LATERAL PLATE SPINAL FIXATION SYSTEM ON BOTH LEVELS. PT REPORTED PAIN NINE DAYS LATER AND X-RAYS IDENTIFIED THAT A CORNEAL FRACTURE HAD DEVELOPED AT L4. THE PT WAS REVISED FOUR DAYS LATER USING A POSTERIOR FIXATION SYSTEM TO STABILIZE THE VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE LATERAL PLATE SYSTEM FIXATION DEVICE, SPINAL, INTERVERTEBRAL KWQ NUVASIVE, INC. NA VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention