BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 8002919 · Received October 24, 2018

    Report

    Report Number
    2031966-2018-00158
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    August 23, 2018
    Report Date
    October 24, 2018
    Manufacturer
    NUVASIVE INC.
    Product Code
    MAX
    PMA / PMN Number
    K141665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION AS PRODUCT REMAINED IN-SITU. NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED. NO RADIOGRAPHS OR IMAGES PROVIDED THAT CONFIRM THE ALLEGED EVENT. A REVIEW OF THE INFORMATION PROVIDED CONFIRMS THE CAUSE OF PATIENTS DEMISE WAS DIAGNOSED AS SEPSIS RESULTING FROM A DUODENAL ULCER PERFORATION AT VATER'S PAPILLA. NO FURTHER INVESTIGATION CAN BE CONDUCTED. LABELING REVIEW: "...CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, LOCAL TO THE OPERATIVE SITE, SIGNS OF LOCAL INFLAMMATION. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME..." "...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. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: NEUROLOGICAL, VASCULAR OR VISCERAL INJURY, INFECTION, DEATH..." "...CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "...STERILIZATION ALL INSTRUMENTS AND IMPLANTS ARE PROVIDED NON-STERILE AND MUST BE STERILIZED PRIOR TO USE. ALL COMPONENTS OF THE COROENT SYSTEM ARE STERILIZABLE BY STEAM AUTOCLAVE USING STANDARD HOSPITAL PRACTICES. IN A PROPERLY FUNCTIONING AND CALIBRATED STEAM STERILIZER...

    Description of Event or Problem · 1

    ON (B)(6) 2018 A PATIENT UNDERWENT THE FIRST OF TWO SCHEDULED PROCEDURES AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L1-L5 AS WELL AS AN ANTERIOR COLUMN RE-ALIGNMENT AT L2-L3 WITH NO REPORTED ISSUES. ON (B)(6) 2018 THE PATIENT UNDERWENT THE SECOND OF TWO SCHEDULED PROCEDURES A POSTERIOR FIXATION AT T3-PELVIS, WITH NO REPORTED ISSUES. ON (B)(6) 2018, ONSET OF JAUNDICE, A BLOOD INSPECTION WAS PERFORMED BY CT CONFIRMED MUCOSAL NECROSIS INSIDE THE LOWER SIDE OF THE STOMACH. DIAGNOSED AS DUODENAL ULCER PERFORATION AT VATER'S PAPILLA BY CONTRAST EXAMINATION AND THE PATIENT WAS TRANSFERRED TO THE GASTROINTESTINAL MEDICINE. ON (B)(6) 2018, SUDDENLY DECREASE IN THE PATIENT'S CONDITION REQUIRED A TRANSFER TO THE ANOTHER INSTITUTION WITH ICU. WHERE THEY CONFIRMED A PERFORATION IN THE DUODENUM TUBE. ON (B)(6) 2018, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842986 NUVASIVE COROENT SYSTEM INTER-VERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC. 7160855P2

    Patients

    Seq Age Sex Outcome Treatment
    1 Death