BEUDAMED
    FDA Adverse Event Death Summary report: N

    GSB GLOBAL SPINAL BALANCE SYSTEM

    MDR report key: 8042952 · Received November 6, 2018

    Report

    Report Number
    2031966-2018-00160
    Event Type
    Death
    Date Received
    November 6, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 5, 2018
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKB
    UDI-DI
    00887517553201
    PMA / PMN Number
    K160989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION AS IT REMAINED IN-SITU. NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED NOR WERE X-RAY FILMS PROVIDED. ALL NUVASIVE DEVICES UTILIZED IN THIS CASE WERE CLEANED AND STERILIZED BY THE USER FACILITY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED THEREFORE, NO FURTHER INVESTIGATION COULD BE COMPLETED AT THIS TIME. LABELING REVIEW: "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), ¿ LOSS OF FIXATION, NONUNION OR DELAYED UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL, VASCULAR OR VISCERAL INJURY, METAL SENSITIVITY OR ALLERGIC REACTION TO A FOREIGN BODY, INFECTION, DECREASE IN BONE DENSITY DUE TO STRESS SHIELDING, PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE, NERVE DAMAGE DUE TO SURGICAL TRAUMA, BURSITIS, DURAL LEAK PARALYSIS, DEATH..." "...THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS PEDICLE SCREW SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT.." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; IMPOTENCE; AND PERMANENT PAIN AND/OR DEFORMITY. RARELY, SOME COMPLICATIONS MAY BE FATAL..."

    Description of Event or Problem · 1

    ON (B)(6) 2018, A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT LEVELS T11-L3 WITHOUT ANY REPORTED ISSUES. ON (B)(6) 2018 PATIENT EXPIRED DUE TO SEPSIS SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883563 GSB GLOBAL SPINAL BALANCE SYSTEM GSB GLOBAL SPINAL BALANCE SYSTEM NKB NUVASIVE INC. 16015535 00887517553201

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RELINE LOCK SCREW 5.5MM 13550000| RELINE MAS SCREW 5.5X40MM 2C 16015540| RELINE MAS SCREW 6.5X40MM 2C 16016540| RELINE MAS TI ROD 5.5X120MM 11355120