BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 9176313 · Received October 10, 2019

    Report

    Report Number
    2031966-2019-00243
    Event Type
    Death
    Date Received
    October 10, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 18, 2019
    Manufacturer
    NUVASIVE
    Product Code
    LXH
    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 ALLEGED. NO RADIOGRAPHS OR IMAGES TO CONFIRM THE REPORTED EVENT. EVEN THOUGH ROOT CAUSE CANNOT BE CONFIRMED, REPORTED INFORMATION SUGGESTS SURGICAL TECHNIQUE MAY HAVE CONTRIBUTED TO ALLEGED EVENT. 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: DAMAGE TO BLOOD VESSELS. RARELY, SOME COMPLICATIONS MAY BE FATAL." INTRA-OPERATIVE WARNINGS: "THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT." "TO MINIMIZE THE RISK OF DAMAGE TO NERVES AND SEGMENTAL VESSELS & CREATION OF PSOAS HEMATOMA, THE FOLLOWING FOUR STEPS ARE ADVISED IN TECHNIQUES WHERE FIXATION SHIMS ARE USED. IDENTIFY WHERE THE SCREW WILL ENGAGE THE SPINE. VISUALLY CHECK FOR NERVES AND SEGMENTAL VESSELS." NO PRODUCT MALFUNCTION REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L1-L4 LEVELS USING COROENT XL. AS PER REPORTER POST INSERTION OF THE CAGE, PATIENT¿S VESSEL WAS DAMAGED. NO ALLEGATION OF PRODUCT MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970934 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE 6910222

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death