BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 8470494 · Received April 1, 2019

    Report

    Report Number
    2031966-2019-00179
    Event Type
    Injury
    Date Received
    April 1, 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 PRODUCT HAS BEEN RETURNED FOR INVESTIGATION AS NO PRODUCT MALFUNCTION HAS BEEN REPORTED. IT IS UNKNOWN WHAT PRODUCTS WERE UTILIZED AT INDEX PROCEDURE. NO RADIOGRAPHS OR CT IMAGES WERE PROVIDED THAT CONFIRM THE ALLEGED EVENT. BASED ON THE INFORMATION PROVIDED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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..." "...CONTRAINDICATIONS: CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: INFECTION, LOCAL TO THE OPERATIVE SITE. SIGNS OF LOCAL INFLAMMATION. PATIENTS WITH KNOWN SENSITIVITY TO THE MATERIALS IMPLANTED. PATIENTS WHO ARE UNWILLING TO RESTRICT ACTIVITIES OR FOLLOW MEDICAL ADVICE. PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME..." NO PRODUCT MALFUNCTION ALLEGED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED AT A PHYSICIAN CONFERENCE: ON AN UNKNOWN DATE A PROCEDURE USING COROENT XL-H WAS PERFORMED. POST-OPERATIVE IMAGE REVEALED PROXIMAL JUNCTIONAL FAILURE. A REVISION PROCEDURE FOR EXTENDING POSTERIOR FIXATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264838 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1