BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 8465483 · Received March 29, 2019

    Report

    Report Number
    2031966-2019-00176
    Event Type
    Injury
    Date Received
    March 29, 2019
    Report Date
    March 2, 2019
    Manufacturer
    NUVASIVE INC.
    Product Code
    ODP
    UDI-DI
    00887517295415
    PMA / PMN Number
    K081611
    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. NO INFORMATION ON PATIENTS' PRE-EXISTING CONDITIONS HAS BEEN PROVIDED NOR RADIOGRAPHS, IMAGES AND/OR SURGICAL NOTES PROVIDED. BASED ON THE INFORMATION PROVIDED AT THIS TIME NO ROOT CAUSE COULD BE DETERMINED. THOUGH PULMONARY EMBOLISM IS A KNOWN COMPLICATION FOR POST-OPERATIVE SPINAL PATIENTS IT IS UNCLEAR IF THE PULMONARY EMBOLISM WAS RELATED TO NUVASIVE PRODUCTS. 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: PULMONARY EMBOLI..."

    Description of Event or Problem · 1

    ON MARCH 2, 2019, THE FOLLOWING EVENT WAS REPORTED AT A PHYSICIAN CONFERENCE ON A COROENT XL-H. CASE 2: ON AN UNKNOWN DATE A PROCEDURE USING COROENT XL-H WAS PERFORMED. POST PROCEDURE, A SYMPTOMATIC PULMONARY EMBOLISM AND BACK SIDE DEEP INFECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259366 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP NUVASIVE INC. 6200450P2 00887517295415

    Patients

    Seq Age Sex Outcome Treatment
    1