BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE ACP SYSTEM

    MDR report key: 12338050 · Received August 18, 2021

    Report

    Report Number
    2031966-2021-00101
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 18, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    KWQ
    UDI-DI
    00887517065179
    PMA / PMN Number
    K203253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AS PRODUCT IS STILL IN-SITU. RADIOGRAPHS PROVIDED CONFIRM THE COMPLAINT. PATIENT'S POST-OPERATIVE PHYSICAL ACTIVITY IS UNKNOWN. PATIENT'S BONE QUALITY IS UNKNOWN. NO PATIENT INJURY REPORTED. DUE TO LACK OF INFORMATION THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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, LOSS OF FIXATION..." "...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. THE NUVASIVE ACP SYSTEM IS DESIGNED TO ASSIST IN PROVIDING AN ADEQUATE BIOMECHANICAL ENVIRONMENT FOR FUSION. IF A DELAYED UNION OR NONUNION OCCURS THE IMPLANT MAY FAIL DUE TO METAL FATIGUE. PATIENTS SHOULD BE FULLY INFORMED OF THE RISK OF IMPLANT FAILURE. 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 SPINAL PROCEDURE TOOK PLACE. ON (B)(6) 2021 IT WAS DISCOVERED DURING A FOLLOW UP THAT A SCREW HAD BACKED OUT. THERE WAS ZERO SUBSIDENCE. NO PATIENT INJURY REPORTED. NO REVISION SURGERY SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237252 NUVASIVE ACP SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NUVASIVE, INCORPORATED 18008317 00887517065179

    Patients

    Seq Age Sex Outcome Treatment
    1 18009354.