BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

    MDR report key: 7473728 · Received April 30, 2018

    Report

    Report Number
    2031966-2018-00046
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 30, 2018
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K090176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE REPORTED EVENT. 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: FRACTURE OF THE VERTEBRA...". WARNINGS, CAUTIONS AND PRECAUTIONS: "...BASED ON THE FATIGUE TESTING RESULTS, WHEN USING THE NUVASIVE X-CORE IVBR SYSTEM, THE SURGEON SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PATIENT WEIGHT, PATIENT ACTIVITY LEVEL, OTHER PATIENT CONDITIONS, ETC. WHICH MAY IMPACT ON THE PERFORMANCE OF THE SYSTEM. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS...". COMPATIBILITY: "...DO NOT USE X-CORE IVBR SYSTEM WITH COMPONENTS OF OTHER SYSTEMS. UNLESS STATED OTHERWISE, NUVASIVE DEVICES ARE NOT TO BE COMBINED WITH THE COMPONENTS OF ANOTHER SYSTEM. ALL COMPONENTS SHOULD BE FINAL TIGHTENED PER THE SPECIFICATIONS IN THE SURGICAL TECHNIQUE. IMPLANTS SHOULD NOT BE TIGHTENED PAST THE LOCKING POINT, AS DAMAGE TO THE IMPLANT MAY OCCUR...". 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...". NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A PATIENT UNDERWENT A VERTEBRAL BODY REPLACEMENT PROCEDURE AT THE T12 LEVEL. POSTERIOR FIXATION WAS PERFORMED WITH J&J EXPEDIUM SYSTEM. ON (B)(6) 2018, A REVISION PROCEDURE WAS PERFORMED DUE TO A VERTEBRAL BODY FRACTURE AT THE L1 LEVEL. THE PREVIOUSLY PLACED X-CORE 2 TI CORE, Ø18MM 21-27MM WAS REMOVED AND A VBR PROCEDURE WAS PERFORMED AT THE T12-L1 LEVELS USING X-CORE 2 TI CORE, O18MM 47-79MM. NO PRODUCT MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316827 NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP NUVASIVE, INC. 7180027006 DR7373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention J&J EXPEDIUM