BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE ACP SYSTEM

    MDR report key: 12026515 · Received June 18, 2021

    Report

    Report Number
    2031966-2021-00079
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 18, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    KWQ
    UDI-DI
    00195377009395
    PMA / PMN Number
    K201078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED AS THE DEVICE REMAINS IN-SITU ALTHOUGH THE COMPLAINT WAS CONFIRMED VIA PROVIDED RADIOGRAPH. THE PATIENTS POST OP ACTIVITY LEVELS OR WHETHER THE PATIENT HAD EXPERIENCED A FALL COULD NOT BE CONFIRMED. A BONE QUALITY REPORT COULD NOT BE PROVIDED. THE PATIENT IS ASYMPTOMATIC NO REVISION IS PLANNED AND THE SURGEON WILL CONTINUE TO MONITOR THE PATIENTS STATUS. NO ROOT CAUSE COULD BE DETERMINED. NO ADDITIONAL INVESTIGATION COULD BE COMPLETED. LABEL REVIEW: " POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION." ''TO PREVENT COMPROMISING THE BONE-SCREW INTERFACE, CAUTION SHOULD BE TAKEN NOT TO OVER-TORQUE THE TEMPORARY FIXATION PIN ONCE IT HAS TIGHTENED AGAINST THE PLATE. TO ALLOW FOR PROPER UTILITY OF THE LOCKING MECHANISM DURING SCREW PLACEMENT, USE A DRILL-GUIDE WITH THE AWL AND/OR DRILL TO CREATE A CENTERED SCREW HOLE INTO THE VERTEBRAL BODIES.'' "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. 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: DURING THE POSTOPERATIVE PHASE IT IS OF PARTICULAR IMPORTANCE THAT THE PHYSICIAN KEEPS THE PATIENT WELL INFORMED OF ALL PROCEDURES AND TREATMENTS. 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

    A FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE FROM THE C4-C6 LEVELS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON (B)(6) IT WAS REPORTED THAT A CERVICAL SCREW BACK OUT HAD OCCURRED AT THE C4 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924307 NUVASIVE ACP SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NUVASIVE, INCORPORATED 18008115 00195377009395

    Patients

    Seq Age Sex Outcome Treatment
    1