BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM

    MDR report key: 10032472 · Received May 7, 2020

    Report

    Report Number
    0001038806-2020-00750
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    January 10, 2020
    Report Date
    May 7, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868029656
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS. OSSEO INTEGRATED DENTAL IMPLANTS ARE AN IMPORTANT TOOL IN PROSTHETIC DENTISTRY AND PROVIDE EDENTULOUS PATIENTS WITH ALTERNATIVE REPLACEMENTS FOR TEETH. ALTHOUGH MOST IMPLANTS ARE EXTREMELY SUCCESSFUL, WITH SURVIVAL RATES OF UP TO 98% FOR IMPLANTS PLACED IN CONTROLLED CLINICAL SETTINGS, IMPLANTS CAN FAIL. ONE PROBLEM ASSOCIATED WITH THIS MINOR DEFECT RATE IS BONE LOSS, WHICH IS LIKELY ATTRIBUTED EXTERNAL FACTORS INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. BONE LOSS IS A PREVIOUSLY INVESTIGATED FAILURE WHICH IS CURRENTLY TRENDED ON A MONTHLY BASIS. CURRENT IMPLANT DESIGN AND MANUFACTURING RISK DOCUMENTATION ASSESS BONE LOSS AS POTENTIAL FAILURES WITH ADEQUATE CONTROLS IN PLACE. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES IMPACTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. WITH NO SIGNALS INDICATING A SYSTEMIC QUALITY ISSUE, NO ESCALATION TO CAPA IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR NOTICED PERI-IMPLANTITIS DURING IMPRESSION COPING. ADDITIONAL SURGERY WAS REQUIRED, NEW IMPLANT WAS PLACED AND AUGMENTATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499969 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I BOST510 2018101180 00844868029656

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention