BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE® RELINE® SYSTEM

    MDR report key: 6996619 · Received November 2, 2017

    Report

    Report Number
    2031966-2017-00161
    Event Type
    Death
    Date Received
    November 2, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 2, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K160989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION AS IT REMAINED IN-SITU. NO ALLEGATION OF PRODUCT MALFUNCTION WAS REPORTED. NO RADIOGRAPHS OR PHOTOGRAPHS PROVIDED FOR EVALUATION. ROOT CAUSE OF PATIENT'S DEMISE IS UNABLE TO BE DETERMINED. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. RARELY, SOME COMPLICATIONS MAY BE FATAL." LEFT IN-SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT UNDERWENT A SPINAL DECOMPRESSION POSTERIOR FUSION PROCEDURE AT T10-L2 LEVELS WITH NO ISSUES. REPORTEDLY, LATER THAT EVENING PATIENT DETERIORATED AND EXPIRED THE NEXT DAY FROM AN UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775816 NUVASIVE® RELINE® SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death