BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE POLYAXIAL SPINAL SCREWS

    MDR report key: 6805756 · Received August 18, 2017

    Report

    Report Number
    2031966-2017-00108
    Event Type
    Death
    Date Received
    August 18, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 18, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K121619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. LABELING REVIEW POTENTIAL ADVERSE EVENTS AND COMPLICATIONS "...AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. RARELY, SOME COMPLICATIONS MAY BE FATAL..."

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT UNDERWENT POSTERIOR PERCUTANEOUS SPINAL FIXATION AT THE T9-S2 LEVELS. AT THE TIME OF CLOSING THE SURGICAL INCISIONS, PATIENT'S OXYGEN SATURATION LEVEL DROPPED AND THE PATIENT WENT INTO CARDIAC ARREST STATE. PATIENT WAS TREATED BY AN ANESTHESIOLOGIST BUT DID NOT RECOVER. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584036 NUVASIVE POLYAXIAL SPINAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death