BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 5435585 · Received February 12, 2016

    Report

    Report Number
    2031966-2016-00002
    Event Type
    Death
    Date Received
    February 12, 2016
    Date of Event
    January 14, 2016
    Report Date
    May 27, 2016
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K151472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THE PATIENT WAS OF MEDIUM BUILD AND THAT THE DILATOR MAY HAVE BEEN INSERTED EXCESSIVELY IN THE ANTERIOR DIRECTION. IT IS UNKNOWN IF APPROPRIATE PATIENT POSITIONING AND IDENTIFICATION OF ANATOMICAL LANDMARKS WAS PERFORMED VIA PALPATION AND/OR FLUOROSCOPY PRIOR TO ADVANCEMENT OF INSTRUMENTATION. THE PATIENT HAS REPORTEDLY RECOVERED FROM THE UNINTENDED INJURY. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS PRODUCT LABELING INDICATES "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." "ADDITIONAL CARE SHOULD BE TAKEN AT THE LOWER LEVELS OF THE LUMBAR SPINE DUE TO THE OBSTRUCTION OF ANATOMICAL STRUCTURES, SUCH AS THE ILIAC CREST AND ILIAC VESSELS, SURGICAL ACCESS FOR THE SUBJECT DEVICE AT THE LEVELS MAY NOT BE FEASIBLE."

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THE PATIENT WAS OF MEDIUM BUILD AND THAT THE DILATOR MAY HAVE BEEN INSERTED EXCESSIVELY IN THE ANTERIOR DIRECTION. IT IS UNKNOWN IF APPROPRIATE PATIENT POSITIONING AND IDENTIFICATION OF ANATOMICAL LANDMARKS WAS PERFORMED VIA PALPATION AND/OR FLUOROSCOPY PRIOR TO ADVANCEMENT OF INSTRUMENTATION. NO RADIOGRAPHS RECEIVED. THE PATIENT HAS REPORTEDLY EXPIRED (B)(6) 2016 AS A RESULT OF SEPSIS. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS: PRODUCT LABELING INDICATES "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY."

    Description of Event or Problem · 1

    ON (B)(6) 2016 A FEMALE PATIENT APPROXIMATELY (B)(6) UNDERWENT A SPINAL FUSION PROCEDURE AT L3-5 FOLLOWED BY PLACEMENT OF POSTERIOR SPINAL FIXATION. THE SURGERY WAS REPORTEDLY COMPLICATED BY ATYPICAL ANATOMY AND REQUIRED AN EXTENDED PERIOD OF TIME TO COMPLETE THE SURGERY. ON (B)(6) 2016 THE PATIENT'S CONDITION DETERIORATED, NECESSITATING TRANSFER TO ANOTHER FACILITY; THE PATIENT WAS DIAGNOSED WITH INTESTINAL DAMAGE. THE PATIENT WAS TREATED AND HAS SINCE RECOVERED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A MEDIUM BUILD FEMALE IN HER 50'S UNDERWENT AN XLIF AT L3-5 WITH POSTERIOR SPINAL FIXATION FOLLOWED BY AN HOUR LONG LAMINOPLASTY WITH NOTED EXCESSIVE BLOOD LOSS. ON (B)(6) 2016 DUE TO DETERIORATION OF THE PATIENT'S CONDITION SHE WAS TRANSFERRED TO ANOTHER FACILITY AND DIAGNOSED WITH INTESTINAL DAMAGE. ON (B)(6) 2016 THE PATIENT EXPIRED FROM SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90669 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR MAX NUVASIVE, INC. 6309855006P QT47391D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| L| R