BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR POSTERIOR TI CAGE

    MDR report key: 17630673 · Received August 28, 2023

    Report

    Report Number
    3007728266-2023-00004
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 25, 2022
    Report Date
    August 28, 2023
    Manufacturer
    3D SYSTEM
    Product Code
    MAX
    UDI-DI
    07640178973466
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE RECEPTION OF THE COMPLAINT, MANUFACTURING FOLDERS OF THE IMPLANTS HAVE BEEN CHECKED. NO ISSUE HAS BEEN DETECTED DURING THE MANUFACTURING, THE CLEANING, THE PACKAGING, AND THE STERILIZATION STEPS. COMPLAINED DEVICES BELONGS TO A BATCH OF (B)(4)UNITS AND (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED WITH NO ISSUE AND NO RETURN FROM THE FIELD. THE STERILIZATION CERTIFICATE HAS BEEN CHECKED AND THE RESULTS ARE CONFORMING TO THE SPECIFICATION (SEE FOLDER "CERTIFICATE D'IRRADIATION"). ALSO, WE HAVE BEEN INFORMED ABOUT THE BACTERIA STRAIN: STAPHYLOCOCCUS EPIDERMIDIS. AS PER NATIONAL LIBRARY OF MEDICINE, THE STAPHYLOCOCCUS EPIDERMIDIS IS A COAGULASE-NEGATIVE, GRAM-POSITIVE COCCI BACTERIA THAT FORM CLUSTERS. IT IS ALSO A CATALASE-POSITIVE AND FACULTATIVE ANAEROBE. THEY ARE THE MOST COMMON COAGULASE-NEGATIVE STAPHYLOCOCCUS SPECIES THAT LIVE ON THE HUMAN SKIN. IN ITS NATURAL ENVIRONMENTS SUCH AS THE HUMAN SKIN OR MUCOSA, THEY ARE USUALLY HARMLESS. MANY TIMES, THESE COAGULASE-NEGATIVE STAPH SPECIES INVADE THE HUMAN BODY VIA PROSTHETIC DEVICES, AT WHICH POINT A SMALL NUMBER OF MICROBES TRAVEL DOWN THE PROSTHETIC DEVICE TO THE BLOODSTREAM. THE BACTERIA, THEN, CAN PRODUCE BIOFILMS THAT HELP TO PROTECT THEM FROM HOST DEFENSE OR ANTIMICROBIALS. THE BELIEF IS THAT STAPHYLOCOCCUS EPIDERMIDIS IS ONE OF THE MOST COMMON CAUSES OF NOSOCOMIAL INFECTION, WITH INFECTION RATES AS HIGH AS THOSE OF STAPHYLOCOCCUS AUREUS. THANKS TO THE KNOWLEDGE OF THE BACTERIA, THE ROUTINE BIOBURDEN MONITORING IN SPINEART CLEAN AREA, THE RESULT OF SPINEART DOSE AUDITS FROM YEARS AND THE FACT THAT THE VALIDATED RANGE OF SPINEART GAMMA RADIATION IS 25-45KGY; THERE IS NO RISK THAT THE IMPLANTED DEVICES COULD CREATE THIS INFECTION. MOREOVER, THE INSTRUMENTATION KIT HAS BEEN VALIDATED TO BE CLEANED, DISINFECTED AND STERILIZED; THE PARAMETERS ARE DEFINED IN SPINEART IFU'S. THUS, THE ORIGIN OF THE CONTAMINATION IS HUMAN AND COULD COME DIRECTLY FROM THE PATIENT OR FROM THE SURGICAL TEAM, DURING THE SURGERY OR JUST AFTER THE SURGERY, DURING THE POST-OPERATIVE CARES.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINT FORM REPORTS A POST-OPERATIVE INFECTION AND A REVISION SURGERY. THE PRIMO SURGERY WAS REALIZED ON (B)(6) 2022. THE PATIENT SUFFERED FROM PAIN SINCE (B)(6)2022. A POST-OPERATIVE INFECTION HAS BEEN DETECTED AND A REVISION SURGERY WAS REALIZED ON (B)(6) 2022 EXPLANTATION OF THE 2 CAGES (THE SCREWS AND THE SETSCREWS WERE NOT REMOVED) BECAUSE OF PSEUDARTHROSIS AND OSTEOLYSIS. ANTIBIOTIC TREATMENT UNTIL (B)(6) 2022. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338822 LUMBAR POSTERIOR TI CAGE LUMBAR POSTERIOR TI CAGE MAX 3D SYSTEM JUT-P6 24 11-S 4-7266 07640178973466

    Patients

    Seq Age Sex Outcome Treatment
    1 Female