BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAS PLIF FIXATION SYSTEM

    MDR report key: 6642461 · Received June 14, 2017

    Report

    Report Number
    2031966-2017-00069
    Event Type
    Death
    Date Received
    June 14, 2017
    Date of Event
    May 29, 2014
    Report Date
    June 14, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K142737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED. ALTHOUGH ROOT CAUSE CANNOT BE DETERMINED, INFORMATION SUGGEST POSSIBLE ILIAC VEIN LACERATION MAY BE A CONTRIBUTING CAUSE. NO RADIOGRAPHS NOR PRODUCT HAVE BEEN RETURNED FOR EVALUATION. LABELING REVIEW NOTES THE FOLLOWING: "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

    RECEIVED INFORMATION STATING ONE DAY POST POSTERIOR LUMBAR INTERBODY FUSION PATIENT REQUIRED AN ADDITIONAL UNSPECIFIED SURGERY THAT WAS CARRIED OUT BY A VASCULAR SURGEON. TWO DAYS POST-VASCULAR SURGERY PATIENT EXPIRED. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422311 MAS PLIF FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death