BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM

    MDR report key: 8700180 · Received June 14, 2019

    Report

    Report Number
    0001038806-2019-00511
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    March 26, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM (BOST411) WAS RETURNED FOR INVESTIGATION WITH AN ATTACHED ATTACHMENT SYSTEM, 4.1MM CERTAIN® CONNECTION, 0.048" DRIVE, 4MM CUFF (30301-04). THIS ASSOCIATED CUFF WILL NOT BE INSPECTED AS PART OF THE INVESTIGATION, AS THE MEDICAL CONDITION ALLEGES BONE LOSS, AND THE LOCATOR IS NOT IN CONTACT AT THE BONE LEVEL. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MODERATE WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND COLLAR. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 1040023 REV C (DIGITAL CALIPER; CAL 3736; OCT 23, 2019). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 22 (FDI) AND USED FOR APPROXIMATELY 1.5 YEARS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2017051634. 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 (2017051634) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (BONE LOSS) OR PRODUCT (BOST411). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). EXPIRATION DATE. DATE RECEIVED BY MANUFACTURER. CHECKED "FOLLOW-UP." CHECKED FOLLOW-UP TYPE. ENTERED EVALUATION CODES. ADDED MANUFACTURER NARRATIVE.

    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). PATIENT'S WEIGHT UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BONE LOSS AND IMPLANT (BOST411 ) WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494453 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM IMPLANT DZE BIOMET 3I 2017051634

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention