BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM

    MDR report key: 11711968 · Received April 22, 2021

    Report

    Report Number
    2031966-2021-00056
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 22, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MQP
    UDI-DI
    00887517360854
    PMA / PMN Number
    K192582
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, PHOTOS PROVIDED COULD NOT CONFIRM THE EVENT. NO RADIOGRAPHS COULD BE PROVIDED TO CONFIRM THE EVENT. REVIEW OF THE REPORTED EVENT IDENTIFIED THE IMPLANT WAS FORCIBLY HAMMERED INTO THE DISC SPACE WHILE UTILIZING THE COUNTER TORQUE. THE INTERBODY VERTEBRAL REPLACEMENT DEVICE IS NOT DESIGNED TO BE HAMMERED INTO PLACE. RATHER THE DISC SPACE IS REQUIRED TO BE FULLY DISTRACTED. THE ROOT CAUSE OF THE EVENT IS THE RESULT OF IMPLANT SELECTION AND EXCESSIVE FORCE. THE PATIENT IS REPORTED TO BE RECOVERING WELL POST REVISION. NO ADDITIONAL INVESTIGATION REQUIRED. LABELING REVIEW "...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..." "...WARNINGS, CAUTIONS AND PRECAUTIONS... THE SUBJECT DEVICE IS INTENDED FOR USE ONLY AS INDICATED...CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT..." "...COMPATIBILITY: DO NOT USE X-CORE EXPANDABLE VBR SYSTEM AND THE X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM WITH COMPONENTS OF OTHER SYSTEMS. UNLESS STATED OTHERWISE, NUVASIVE DEVICES ARE NOT TO BE COMBINED WITH THE COMPONENTS OF ANOTHER SYSTEM..." "...PRE-OPERATIVE WARNINGS... CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "...MEASURING CORE HEIGHT...USE THE X-CORE 2 EXPANDABLE VBR HEIGHT CALIPER TO MEASURE THE DEFECT HEIGHT. PLACE CALIPER TIPS WITHIN THE VOID OPENING, CONFIRMING EACH TIP IS SEATED FLUSH ONTO THE SUPERIOR AND INFERIOR ENDPLATES (FIG. 48). UNDER NO DISTRACTION, OBTAIN THE READING OF THE DEFECT HEIGHT AS INDICATED ON EITHER THE TOP OR SIDE OF THE MEASURING DEVICE. IF ADDITIONAL DISTRACTION IS REQUIRED, UTILIZE THE X-CORE 2 EXPANDABLE VBR DISTRACTOR TO DO SO (FIG. 49). THIS INSTRUMENT WILL NOT PROVIDE HEIGHT READING BUT WILL HELP TO DISTRACT THE DISC SPACE. 9500968C..."

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A CORPECTOMY PROCEDURE WHERE THE L2 VERTEBRAL BODY WAS BEING REPLACED. DURING THE PROCEDURE THE VERTEBRAL IMPLANT WAS TWO LARGE FOR THE SPACE AND WAS FORCIBLY HAMMERED INTO PLACE. ON (B)(6) 2021 A HOSPITAL NURSE CONTACTED THE INVOLVED REP TO INFORM THEN A PORTION OF THE COUNTER TORQUE INSTRUMENT WAS MISSING FROM THE DEVICE AND POST OPERATIVE IMAGES CONFIRMED THAT MISSING PORTION WAS LEFT IN PATIENT. ON (B)(6) 2021 A REVISION PROCEDURE OCCURRED AND THE RETRIEVED FRAGMENT WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607874 NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP NUVASIVE, INCORPORATED 6790153 EM1972 00887517360854

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention