BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 8081726 · Received November 16, 2018

    Report

    Report Number
    2031966-2018-00169
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 16, 2018
    Manufacturer
    NUVASIVE
    Product Code
    NKB
    UDI-DI
    00887517552853
    PMA / PMN Number
    K132014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. IT IS UNKNOWN IF ALLEGED EVENT IS RELATED TO PRODUCT. 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: EARLY OR LATE INFECTION;..." "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: INFECTION ..." RELATED MDR 2031966 -2018 -00155. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    POST REVISION SURGERY, PATIENT WAS REPORTED TO HAVE AN INFECTION. AS PER REPORTER PATIENT WAS PROVIDED ANTIBIOTICS AND UNDERWENT A SALINE WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916641 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE 16014540 00887517552853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other