BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 6704687 · Received July 11, 2017

    Report

    Report Number
    2031966-2017-00080
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    September 8, 2016
    Report Date
    July 11, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NBK
    UDI-DI
    00887517594181
    PMA / PMN Number
    K143684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE EVENT. INFORMATION RECEIVED FROM THE PHYSICIAN INDICATES PATIENT WAS DIAGNOSED WITH PSEUDOARTHROSIS 15 MONTHS POST INITIAL SURGERY. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS; AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)..."

    Description of Event or Problem · 1

    ON (B)(6) 2016, PATIENT HEARD A "POP" AND WAS EXPERIENCING BACK PAIN. PATIENT WAS DIAGNOSED WITH "A BROKEN ROD". IT WAS REPORTED A CT SCAN OF THE SPINE INDICATED A FRACTURE OF THE CONNECTOR RODS. ON (B)(6) 2016, PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE FRACTURED ROD AND REVISE THE INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485488 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NBK NUVASIVE, INC. 15455300 00887517594181

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR