BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9634300 · Received January 27, 2020

    Report

    Report Number
    0001038806-2020-00201
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    November 19, 2019
    Report Date
    April 1, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM (BOST510) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT SIGNS OF BONE TISSUE ATTACHMENT ABOUT THE IMPLANT THREADS. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 1040025 REV C. THE PATIENT IS NOTED TO HAVE A HISTORY OF BRUXISM, WHICH COULD CONTRIBUTE TO SINUS PERFORATION OVER TIME. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 13 (UNIVERSAL) AND USED FOR APPROXIMATELY 8 MONTHS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2018090902. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2018090902) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (SINUS PERFORATION + BONE LOSS) OR PRODUCT (BOST510). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (BOST510) PERFORATED THE MAXILLARY SINUS AT TOOTH LOCATION 13. IMPLANT WAS REMOVED DURING THE CLOSURE OF THE FISTULA. BONE LOSS AND DEHISCENCE WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95668 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2018090902

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention