BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 8465696 · Received March 29, 2019

    Report

    Report Number
    2031966-2019-00177
    Event Type
    Injury
    Date Received
    March 29, 2019
    Report Date
    March 2, 2019
    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 ALLEGATION OF PRODUCT MALFUNCTION HAS BEEN REPORTED NOR INFORMATION ON PATIENTS¿ PRE-EXISTING CONDITION PROVIDED. NO RADIOGRAPHS, IMAGES OR SURGICAL NOTES PROVIDED. BASED ON THE INFORMATION PROVIDED ROOT CAUSE COULD NOT BE DETERMINED. LABELING REVIEW: "...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: 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...". PRODUCT WAS LEFT IN-SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS ADVERSE EVENT WAS REPORTED AT PHYSICIAN CONFERENCE. CASE 3: A PROCEDURE USING COROENT XL-H WAS PERFORMED. A NERVOUS DISORDER AND PSEUDOARTHROSIS OCCURRED POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256752 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1