BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11870427 · Received May 24, 2021

    Report

    Report Number
    2031966-2021-00070
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 24, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE REPORTED INFORMATION STATES THAT COMPETITOR HARDWARE WAS USED SIMULTANEOUSLY WITH NUVASIVE HARDWARE WHICH IS AN OFF-LABEL USE WHICH IS MOST LIKELY THE CAUSE AND/OR CONTRIBUTOR OF THE ADVERSE EVENT. THE ROOT CAUSE CANNOT BE DETERMINED. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE NERVE DAMAGE DUE TO SURGICAL TRAUMA". "COMPATIBILITY: UNLESS STATED OTHERWISE, NUVASIVE DEVICES ARE NOT TO BE COMBINED WITH THE COMPONENTS OF ANOTHER SYSTEM".

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE FIRST PART OF A TWO PART PROCEDURE AN EXTREME LATERAL INTERBODY FUSION WAS PERFORMED AT L3/L5. ON (B)(6) 2017 THE SECOND PART OF THE PROCEDURE WAS CONDUCTED A POSTERIOR LUMBAR INTERBODY FUSION AT L3/S2AI WHERE A COMPETITOR'S CAGE WAS INSERTED AT L5/S. ON (B)(6) 2021 A REVISION SURGERY WAS DONE DUE TO THE PATIENT EXPERIENCING CAUDA EQUINA SYMPTOMS IN THE LOWER RIGHT LIMB. AN EXTREME LATERAL INTERBODY FUSION WAS PERFORMED ON L1/L3 AND A LOOSE COMPETITOR'S SCREW WAS REPLACED AT T12. IT WAS REPORTED THAT A COMPETITOR'S SCREW WAS CONNECTED WITH NUVASIVE HARDWARE DURING THIS PROCEDURE AND T5/T12 IS FIXED WITH COMPETITOR'S PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766031 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention