BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE ACP SYSTEM

    MDR report key: 11873692 · Received May 24, 2021

    Report

    Report Number
    2031966-2021-00071
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 24, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    KWQ
    PMA / PMN Number
    K203253
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED AS DEVICE IS STILL IN-SITU. RADIOGRAPH PROVIDED CONFIRMED COMPLAINT HOWEVER POOR QUALITY OF IMAGE. THE PATIENT'S POST-OP PHYSICAL ACTIVITY IS UNKNOWN. PATIENT'S BONE QUALITY IS UNKNOWN. THE ROOT CAUSE IS UNKNOWN AT THIS TIME THOUGH REVIEW OF THE PROVIDED INFORMATION SUGGESTS POSSIBLE INCOMPLETE SCREW PLACEMENT, IMPLANT DAMAGE, POOR BONE QUALITY, OR EXCESSIVE PHYSICAL ACTIVITY. NO ADDITIONAL CAN BE COMPLETED AT THIS TIME. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), 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. CARE SHOULD BE TAKEN TO ENSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "PATIENT EDUCATION: 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 DEVICE(S) 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) 2020 A SPINAL PROCEDURE WAS CONDUCTED. DURING A FOLLOW-UP ON (B)(6) 2021, A CAM SEPARATION WAS DISCOVERED THROUGH RADIOGRAPH. A REVISION SURGERY IS PLANNED FOR (B)(6) 2021 WHERE A POSTERIOR CERVICAL FUSION WILL BE PERFORMED AT C3-T3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769816 NUVASIVE ACP SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NUVASIVE, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR