BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 5551725 · Received April 6, 2016

    Report

    Report Number
    2031966-2016-00025
    Event Type
    Death
    Date Received
    April 6, 2016
    Date of Event
    March 10, 2016
    Report Date
    April 1, 2016
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K141665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE REASON FOR THE BLOOD LOSS IS UNKNOWN. THERE WAS DIFFICULTY REPORTED WITH PLACEMENT OF THE PEDICLE AND/OR ILIAC SCREWS. IT IS NOT KNOWN IF THESE DIFFICULTIES CONTRIBUTED TO THE EVENT. THERE IS NO KNOWN MALFUNCTION OF THE NUVASIVE INTERBODY IMPLANTS NOR ANY INFORMATION SUGGESTING DIFFICULTY IN PLACEMENT OF THE INTERBODY IMPLANTS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INTERBODY DEVICES NOTES NO MATERIAL NONCONFORMANCES, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS RELATED TO THE INTERBODY IMPLANTS. NUVASIVE IMPLANTS MET ACCEPTANCE CRITERIA UPON RELEASE. REVIEW OF LABELING NOTES: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: ..." "...NERVE DAMAGE DUE TO SURGICAL TRAUMA..." "...DURAL LEAK PARALYSIS DEATH." NO MALFUNCTION KNOWN TO HAVE OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AN (B)(6) MALE UNDERWENT AN XLIF PROCEDURE AT L2-L5 WITH NO PROBLEMS REPORTED. ON (B)(6) 2016 A POSTERIOR SPINAL CORRECTION INVOLVING A PONTE OSTEOTOMY WAS PERFORMED AT L5-S1. THE PROCEDURE WAS 7 HOURS LONG AS A RESULT OF DIFFICULTY WITH SCREW BACK OUT DURING FINAL TIGHTENING WITH A BLOOD LOSS TOTAL OF 2000CC. J&J VIPER SACRAL-ALAR-ILIAC SCREWS AS WELL AS ZIMMER PATHFINDER PEDICLE SCREWS WERE USED IN CONJUNCTION WITH NUVASIVE INTERBODY IMPLANTS. DURING CLOSURE OF THE SURGICAL WOUND THE PATIENT SUFFERED A CARDIAC FAILURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207200 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INC. 6080823006P QT44755Y

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death