BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 6994273 · Received November 1, 2017

    Report

    Report Number
    2031966-2017-00158
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    January 6, 2011
    Report Date
    November 1, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    UDI-DI
    00887517062352
    PMA / PMN Number
    K073278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION AS IT REMAINS IN-SITU. NO PRODUCT MALFUNCTION HAS BEEN REPORTED NOR REVISION SURGERY. IT IS UNKNOWN IF PATIENT FOLLOWED POST-OPERATIVE DIRECTIONS. 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 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

    ON (B)(6) 2010, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. A THIRD PARTY 12 MONTH POST-OPERATIVE RADIOGRAPHIC FILM REPORTED A SUPERIOR L4 SPINOUS PROCESS FRACTURE. IT WAS REPORTED THE PATIENT HAD NO NEUROLOGIC SYMPTOMS THROUGHOUT THE POSTOPERATIVE COURSE AND WAS NEUROLOGICALLY INTACT, PATIENT HAD SUCCESSFUL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771970 SPINOUS PROCESS PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP NUVASIVE, INC. 7577045 00887517062352

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other