BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM,

    MDR report key: 14939687 · Received July 6, 2022

    Report

    Report Number
    2031966-2022-00119
    Event Type
    Death
    Date Received
    July 6, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 6, 2022
    Manufacturer
    NUVASIVE INC.
    Product Code
    MAX
    PMA / PMN Number
    K203714
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS REPORTED, NO NUVASIVE PRODUCT WAS RETURNED, NO RADIOGRAPHS OR IMAGES PROVIDED SO THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE REPORTED EVENT FOUND NO PRODUCT MALFUNCTION WAS ALLEGED OR IDENTIFIED. INFORMATION RECEIVED FROM THE ATTENDING REP NOTED THE PATIENT EXPERIENCED SUBSTANTIAL BLEEDING AS A RESULT OF EXCESSIVE BONE WORK REQUIRED FOR PROCEDURAL GOALS WERE SUSPECTED AS THE ROOT CAUSE BUT NO DEFINITIVE ROOT CAUSE COULD BE CONFIRMED. ADDITIONALLY IT WAS IDENTIFIED THAT NUVASIVE INTRERBODY'S WERE COMBINED WITH OTHER MANUFACTURERS PRODUCTS AND CONSIDERED OFF LABEL AS NO TESTING HAS BEEN COMPLETED AND RESULTS MAY VARY. LABELING REVIEW: "...CONTRAINDICATIONS: CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: 5. PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY. 6. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME..." ...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: EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; PLEURAL EFFUSIONS, HEMOTHORAX, CHYLOTHORAX, PNEUMOTHORAX, SUBCUTANEOUS EMPHYSEMA, NEED FOR CHEST TUBE INSERTION, INTERCOSTAL NEURALGIA, RIB FRACTURE, DIAPHRAGM INJURY; ATELECTASIS; IMPOTENCE; 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: 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..." "...COMPATIBILITY: DO NOT USE COROENT THORACOLUMBAR SYSTEM WITH COMPONENTS OF OTHER SYSTEMS. UNLESS STATED OTHERWISE, NUVASIVE DEVICES ARE NOT TO BE COMBINED WITH THE COMPONENTS OF ANOTHER SYSTEM..." "...PRE-OPERATIVE WARNINGS: 1. ONLY PATIENTS THAT MEET THE CRITERIA DESCRIBED IN THE INDICATIONS SHOULD BE SELECTED. 2. PATIENT CONDITION AND/OR PREDISPOSITIONS SUCH AS THOSE ADDRESSED IN THE AFOREMENTIONED CONTRAINDICATIONS SHOULD BE AVOIDED. 5. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." LEFT IN-SITU.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBER INTERBODY FUSION L4/5 WITH ANOTHER MANUFACTURES FIXATION T2-PELVIS DURING WHICH MUCH BONE WORK WAS DONE TO THIS PATIENT AND SEVERE BLOOD LOSS TOOK PLACE WHERE THE PATIENT LOST 13 LITERS OF BLOOD AND PASSED AWAY DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047985 NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM, INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC. ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Death UNKNOWN MANUFACTURERS DEVICES