BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVISION JJB

    MDR report key: 2186743 · Received July 22, 2011

    Report

    Report Number
    2031966-2011-00037
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 15, 2010
    Report Date
    July 22, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    GWF
    PMA / PMN Number
    K062765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NUVASIVE REFERENCE (B)(4). A SPECIFIC DEVICE HAS NOT BEEN IDENTIFIED THAT WOULD ALLOW A DETAILED FUNCTIONAL INVESTIGATION. A MALFUNCTION IS NOT KNOWN TO HAVE OCCURRED AND NO ROOT CAUSE HAS BEEN IDENTIFIED. AN APPARENTLY EXTENDED NERVE RETRACTION PERIOD OCCURRED DURING SURGERY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUBSEQUENT REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED OF AN INJURY FOLLOWING INVOLVING THE (B)(6); THE INJURY WAS REPORTED TO HAVE OCCURRED DUE TO EXTENSIVE NERVE RETRACTION. THERE WAS POST-OPERATIVE MOTOR FUNCTION LOSS IN THE PATIENT'S ANKLES AND SOME SENSORY FUNCTION LOSS ON THE PLANTAR AND DORSAL ASPECTS OF HIS FEET. PERMANENT DAMAGE HAS BEEN ALLEGED IN THE LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROVISION JJB NERVE MONITORING SYSTEM GWF NUVASIVE, INC. JJB

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability