BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE® RELINE® SYSTEM

    MDR report key: 6955905 · Received October 17, 2017

    Report

    Report Number
    2031966-2017-00140
    Event Type
    Death
    Date Received
    October 17, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 17, 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." THE DEVICE WAS LEFT IN-SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT UNDERWENT A POSTERIOR CORRECTION AND FUSION PROCEDURE AT T4-S1 LEVELS WITH NO REPORTED ISSUES. POST-OPERATIVELY THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734654 NUVASIVE® RELINE® SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Death