BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE

    MDR report key: 18048772 · Received November 1, 2023

    Report

    Report Number
    2031966-2023-00251
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 1, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MQP
    UDI-DI
    00887517228574
    PMA / PMN Number
    K193506
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED AND NO RADIOGRAPHS WERE PROVIDED CONFIRMING THE ALLEGED EVENT. REVIEW ON THE INFORMATION PROVIDED IDENTIFIED THE VERTEBRAL BODY REPLACEMENT WAS PLACED WITHOUT THE REQUIRED SUPPLEMENTAL FIXATION. ADDITIONALLY THE PATIENT WAS REPORTED TO HAVE POOR BONE QUALITY. THE ROOT CAUSE OF THE REPORTED SUBSIDENCE APPEARS TO BE A COMBINATION OF THE PATIENT POOR BONE QUALITY, IMPLANT SELECTION/PLACEMENT, AND A FAILURE TO PROVIDE SUPPLEMENTAL FIXATION AND IS CONSIDERED IMPROPER PROCEDURE. NO ADDITIONAL REPORTING REQUIRED. LABEL REVIEW "INDICATIONS FOR USE - THE NUVASIVE X-CORE IVBR SYSTEM IS INTENDED TO BE USED WITH SUPPLEMENTAL INTERNAL SPINAL FIXATION SYSTEMS THAT ARE CLEARED BY THE FDA FOR USE IN THE THORACIC AND LUMBAR SPINE." "CONTRAINDICATIONS - CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY. 6. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME." "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS - AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)... PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE." "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. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS." "CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE."

    Description of Event or Problem · 0

    ON (B)(6) 2023 A PATIENT UNDERWENT A INTERVERTEBRAL REPLACEMENT PROCEDURE WHERE A VERTEBRAL SPACER WAS PLACED BETWEEN L2 AND L3 WITHOUT UTILIZATION OF POSTERIOR FIXATION. THE SURGERY WAS COMPLETED WITHOUT ISSUE. IN (B)(6) 2023 THE PATIENT BEGAN TO EXPERIENCE PAIN AND IT WAS DISCOVERED THAT IMPLANT HAD SUBSIDED INTO THE L3 VERTEBRAL BODY. ON (B)(6) 2023 A REVISION OCCURRED WHERE THE IMPLANT WAS REPOSITIONED AND POSTERIOR FIXATION WAS IMPLANTED FROM T12 TO L4. THE PATIENT IS DOING WELL POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032857 NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP NUVASIVE, INCORPORATED 7180027006 PD0877 00887517228574

    Patients

    Seq Age Sex Outcome Treatment
    1 Female