BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE MODULUS XLIF INTERBODY SYSTEM

    MDR report key: 17686198 · Received September 5, 2023

    Report

    Report Number
    2031966-2023-00185
    Event Type
    Death
    Date Received
    September 5, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 5, 2023
    Manufacturer
    NUVASIVE INC
    Product Code
    MAX
    PMA / PMN Number
    K201692
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED AS NO MALFUNCTION WAS ALLEGED. DUE TO A COMPLETE LACK OF INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED DEATH IS UNKNOWN. THE LOCATION, AMOUNT AND CAUSE OF THE REPORTED BLEEDING WAS NOT PROVIDED. THE CAUSE OF THE REPORTED DEATH WAS NOT PROVIDED. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED AT THIS TIME. AN ADDITIONAL REPORT WILL BE FILED SHOULD MORE INFORMATION BE PROVIDED. LABELING REVIEW: "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, DEATH.". "WARNINGS, CAUTIONS AND PRECAUTIONS THE SUBJECT DEVICE IS INTENDED FOR USE ONLY AS INDICATED. THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT... CARE SHOULD BE TAKEN TO ENSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE.". "PRE-OPERATIVE WARNINGS ... CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT.". "METHOD OF USE PLEASE REFER TO THE SURGICAL TECHNIQUE FOR THIS DEVICE.". "INFORMATION TO OBTAIN A SURGICAL TECHNIQUE MANUAL OR SHOULD ANY INFORMATION REGARDING THE PRODUCTS OR THEIR USES BE REQUIRED, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR NUVASIVE DIRECTLY AT (B)(4). YOU MAY ALSO EMAIL: (B)(4)." 9402506-EN H-2022-06. NO DEVICE RETURNED.

    Description of Event or Problem · 0

    AN EXTREME LATERAL INTERBODY FIXATION WAS CONDUCTED AT L3/5. AN INTERBODY WAS INSERTED AT L4/5 WITH NO PROBLEM. ANOTHER INTERBODY WAS INSERTED AT L3/4 WHERE BLEEDING OCCURRED IN THE SURGICAL FIELD AND HEMOSTASIS WAS PERFORMED WITH BIPOLAR FORCEPS HOWEVER, THE LOCATION AND AMOUNT OF BLEEDING WAS NOT PROVIDED. AN ADDITIONAL NOTIFICATION WAS RECEIVED 28 DAYS LATER STATING THE PATIENT HAS PASSED AWAY AND THE CAUSAL RELATION BETWEEN THE BLEEDING AND DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639598 NUVASIVE MODULUS XLIF INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death