BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11808538 · Received May 11, 2021

    Report

    Report Number
    2031966-2021-00065
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 11, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517594204
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. RADIOGRAPH PROVIDED CONFIRMED THE ALLEGED MALFUNCTION. THE PATIENT'S POST-OPERATIVE PHYSICAL ACTIVITY IS UNKNOWN. BONE FUSION WAS OBSERVED. DUE TO LACK OF INFORMATION THE ROOT CAUSE CANNOT BE DETERMINED AND 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: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)..." "...WARNINGS, CAUTIONS AND PRECAUTIONS: IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT..." "...PATIENT EDUCATION: THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. 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 EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED..." "...POST-OPERATIVE WARNINGS: DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION, AS WELL AS TO OTHER COMPLICATIONS. TO ENSURE THE EARLIEST POSSIBLE DETECTION OF SUCH CATALYSTS OF DEVICE DYSFUNCTION, THE DEVICES MUST BE CHECKED PERIODICALLY POSTOPERATIVELY, USING APPROPRIATE RADIOGRAPHIC TECHNIQUES..."

    Description of Event or Problem · 1

    ON (B)(6) 2018 A PATIENT UNDERWENT A SPINAL PROCEDURE. ON (B)(6) 2021 THE PATIENT REPORTED HEARING A SOUND WHEN BENDING DOWN. ON (B)(6) 2021 AN X-RAY REVEALED A ROD FRACTURE AT L4/5. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED AND BONE FUSION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702734 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 15455500 CT87043 00887517594204

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR