BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE® COROENT® THORACOLUMBAR SYSTEM

    MDR report key: 7837450 · Received August 31, 2018

    Report

    Report Number
    2031966-2018-00138
    Event Type
    Death
    Date Received
    August 31, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 31, 2018
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K170962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE XRAYS PROVIDED TO CONFIRM THE ALLEGED EVENT. LABELING: "...AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. RARELY, SOME COMPLICATIONS MAY BE FATAL..." "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEATH..."

    Description of Event or Problem · 1

    ON (B)(6) 2018 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE. REPORTEDLY, PATIENT SUFFERED COMPLICATIONS RELATED TO A BOWEL PERFORATION AND PASSED AWAY SEVERAL DAYS POST-SURGERY. AT THIS TIME, THERE IS NO PRODUCT MALFUNCTION REPORTED OR ALLEGATION THAT NUVASIVE PRODUCT CONTRIBUTED TO ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680536 NUVASIVE® COROENT® THORACOLUMBAR SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death