BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 7121741 · Received December 15, 2017

    Report

    Report Number
    2031966-2017-00179
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 15, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    ODP
    PMA / PMN Number
    K081611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE REPORTED EVENT. PRODUCT REMAINS IN-SITU. POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: "...AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: DAMAGE TO BLOOD VESSELS..." "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: NEUROLOGICAL, VASCULAR OR VISCERAL INJURY..." PRODUCT REMAINS IN-SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE. AFTER PLACING THE ANTERIOR COLUMN REALIGNMENT CAGE, BLEEDING WAS OBSERVED. DOCTOR BELIEVED THE INFERIOR VENA CAVA WAS DAMAGED AND PERFORMED PRESSURE HEMOSTASIS. REPORTEDLY, THE NEXT DAY, BLEEDING STOPPED AND CT IMAGES DID NOT SHOW ANY HEMATOMA(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899842 NUVASIVE COROENT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE ODP NUVASIVE, INC. 6300445P2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention