BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11845270 · Received May 18, 2021

    Report

    Report Number
    2031966-2021-00067
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 18, 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 DEVICE WAS RETURNED FOR EVALUATION. NO RADIOGRAPHS OR IMAGES WERE PROVIDED TO CONFIRM THE EVENT. REVIEW OF THE REPORTED INFORMATION STATES PATIENT PHYSICAL ACTIVITY WAS THE ROOT CAUSE OF THE VERTEBRAL FRACTURE. NO PRODUCT FAILURE WAS ALLEGED OR IDENTIFIED. NO ADDITIONAL INVESTIGATION REQUIRED. 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: FRACTURE OF THE VERTEBRA..." "... PATIENT EDUCATION: THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN..."

    Description of Event or Problem · 1

    ON (B)(6) 2021 AN EXTREME LATERAL INTERBODY FUSION REVISION WAS CONDUCTED AT L1/L3 FOR CORRECTION OF ALIGNMENT AND ADDITION OF INTERBODY CAGE SPACERS AT L1/L3. NO PRODUCT FAILURE OR DEFECT REPORTED. ON (B)(6) 2021 IT WAS REPORTED THAT T10 FRACTURED DUE TO PATIENT PHYSICAL ACTIVITY. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED WHERE THE FIXATION WAS EXTENDED TO T4/S2AI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737336 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention