BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE MODULUS ALIF SYSTEM

    MDR report key: 11760512 · Received May 3, 2021

    Report

    Report Number
    2031966-2021-00061
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    October 6, 2020
    Report Date
    May 3, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    OVD
    UDI-DI
    00887517020154
    PMA / PMN Number
    K210271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AS NO MALFUNCTION WAS ALLEGED AND PRODUCT IS STILL IN-SITU. RADIOGRAPH PROVIDED DID NOT CONFIRM THE REPORTED INFECTION HOWEVER A COMPLETE SUBSIDENCE OF THE L4-L5 INTERBODY IMPLANT INTO THE L5 VERTEBRAL BODY WITH POSSIBLE CUT-OUT OF BILATERAL L5 PEDICLE SCREWS; RADIOLUCENCY IN THE L4 VERTEBRAL BODY, ETIOLOGY UNKNOWN WAS IDENTIFIED. MEDICAL INTERVENTION INCLUDED ANTIBIOTICS AND AN ABDOMINAL DRAIN. NO REVISION SURGERY NEEDED PER SURGEON'S PREROGATIVE. NUVASIVE INSTRUMENTS ARE CLEANED AND STERILIZED BY USER FACILITY AND STERILIZATION RECORDS WERE NOT PROVIDED. THE ROOT CAUSE HAS NOT BE DETERMINED. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "...CONTRAINDICATIONS: CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: 1. INFECTION, LOCAL TO THE OPERATIVE SITE..." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: INFECTION..." "...PRE-OPERATIVE WARNINGS: FOR STERILE IMPLANTS: ASSURE HIGHLY ASEPTIC SURGICAL CONDITIONS, AND USE ASEPTIC TECHNIQUE WHEN REMOVING THE MODULUS ALIF IMPLANT FROM ITS PACKAGING. INSPECT THE IMPLANT AND PACKAGING FOR SIGNS OF DAMAGE, INCLUDING SCRATCHED OR DAMAGED DEVICES OR DAMAGE TO THE STERILE BARRIER. DO NOT USE THE MODULUS ALIF IMPLANTS IF THERE IS ANY EVIDENCE OF DAMAGE..." "...PACKAGING: ALL IMPLANTS AND INSTRUMENTS PROVIDED STERILE ARE INTENDED FOR SINGLE USE ONLY. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED..." "...HANDLING OF THE STERILE IMPLANT: BEFORE REMOVING THE IMPLANTS FROM THE PACKAGE, MAKE SURE THAT THE PROTECTIVE PACKAGING IS UNOPENED AND UNDAMAGED. IF THE PACKAGING IS DAMAGED, THE IMPLANTS HAVE TO BE CONSIDERED AS NON-STERILE AND MAY NOT BE USED. NOTE THE STERILE EXPIRY DATE. IMPLANTS WITH ELAPSED STERILE EXPIRY DATES HAVE TO BE CONSIDERED AS NON-STERILE AND MAY NOT BE USED. TAKE PARTICULAR CARE THAT ASEPTIC INTEGRITY IS ASSURED DURING REMOVAL OF THE IMPLANT FROM THE INNER PACKAGING. OPEN THE PACKAGES CAREFULLY. TAKE SUITABLE MEASURES TO ENSURE THAT THE IMPLANT DOES NOT COME INTO CONTACT WITH OBJECTS THAT COULD DAMAGE ITS SURFACES. USE ONLY THE RECOMMENDED INSTRUMENTS FOR IMPLANTATION OF THE IMPLANTS. DAMAGED IMPLANTS MUST NOT BE USED..." "...CLEANING AND DECONTAMINATION: ALL NON-STERILE INSTRUMENTS MUST FIRST BE THOROUGHLY CLEANED USING THE VALIDATED METHODS PRESCRIBED IN THE NUVASIVE CLEANING AND STERILIZATION INSTRUCTIONS DOC #9400896 BEFORE STERILIZATION AND INTRODUCTION INTO A STERILE SURGICAL FIELD. CONTAMINATED INSTRUMENTS SHOULD BE WIPED CLEAN OF VISIBLE SOIL AT THE POINT OF USE, PRIOR TO TRANSFER TO A CENTRAL PROCESSING UNIT FOR CLEANING AND STERILIZATION. THE VALIDATED CLEANING METHODS INCLUDE BOTH MANUAL AND AUTOMATED CLEANING. VISUALLY INSPECT THE INSTRUMENTS FOLLOWING PERFORMANCE OF THE CLEANING INSTRUCTIONS TO ENSURE THERE IS NO VISUAL CONTAMINATION OF THE INSTRUMENTS PRIOR TO PROCEEDING WITH STERILIZATION. IF POSSIBLE CONTAMINATION IS PRESENT AT VISUAL INSPECTION, REPEAT THE CLEANING STEPS. CONTAMINATED INSTRUMENTS SHOULD NOT BE USED, AND SHOULD BE RETURNED TO NUVASIVE. CONTACT YOUR LOCAL REPRESENTATIVE OR NUVASIVE DIRECTLY FOR ANY ADDITIONAL INFORMATION RELATED TO CLEANING OF NUVASIVE SURGICAL INSTRUMENTS. INSTRUMENTS WITH A D PREFIX PART NUMBER MAY BE DISASSEMBLED. PLEASE REFER TO THE ADDITIONAL DISASSEMBLY INSTRUCTIONS FOR THESE INSTRUMENTS..." "...STERILIZATION: ALL NON-STERILE INSTRUMENTS ARE STERILIZABLE BY STEAM AUTOCLAVE USING STANDARD HOSPITAL PRACTICES, IN ADDITION TO NUVASIVE¿S VALIDATED PARAMETERS. IN A PROPERLY FUNCTIONING AND CALIBRATED STEAM STERILIZER, EFFECTIVE STERILIZATION MAY BE ACHIEVED USING THE PARAMETERS PRESCRIBED IN THE NUVASIVE CLEANING AND STERILIZATION INSTRUCTIONS DOC #9400896...".

    Description of Event or Problem · 1

    ON (B)(6) 2020 A PATIENT UNDERWENT AN ANTERIOR LATERAL INTERBODY FUSION PROCEDURE AT L3-L4 AND L4-L5 AND DEVELOPED (B)(6). THE INFECTION WAS CONTROLLED AND CURED WITH ANTIBIOTICS AND AN ABDOMINAL DRAIN. NO SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656608 NUVASIVE MODULUS ALIF SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD NUVASIVE, INCORPORATED 1882064P2 00887517020154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 1921042P2| ATTRAX