BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE ACP SYSTEM

    MDR report key: 12351248 · Received August 20, 2021

    Report

    Report Number
    2031966-2021-00104
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 20, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    KWQ
    UDI-DI
    00195377009395
    PMA / PMN Number
    K203253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED AS PRODUCTS ARE STILL IN-SITU. RADIOGRAPHS CONFIRM THE COMPLAINT. PATIENT'S POST-OPERATIVE PHYSICAL ACTIVITY IS UNKNOWN. PATIENT'S BONE QUALITY IS UNKNOWN. THE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER BONE QUALITY AND EXCESSIVE POST OPERATIVE PHYSICAL ACTIVITY IS SUSPECTED AS CAUSE OR CONTRIBUTOR. 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 COMPONENTS." "WARNINGS, CAUTIONS AND PRECAUTIONS: CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. THESE DEVICES ARE NOT INTENDED TO BE USED AS THE SOLE SUPPORT FOR THE SPINE. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF PATIENT ANATOMY MAY PRESENT LIMITATIONS ON THE SIZE OF THE CHOSEN IMPLANTS. CARE SHOULD BE TAKEN TO ENSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "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." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT." "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."

    Description of Event or Problem · 1

    ON (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3/4 AND C7/T1. IT WAS IDENTIFIED ON (B)(6) 2021 THAT BOTH PLATES HAVE MIGRATED AND HAVE SCREWS BACKING OUT. THERE IS NO REVISION SURGERY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246248 NUVASIVE ACP SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NUVASIVE, INCORPORATED 18008115 00195377009395

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR