BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® WITH DCD® TAPERED IMPLANT 5/4 X 10MM

    MDR report key: 8735240 · Received June 26, 2019

    Report

    Report Number
    0001038806-2019-00578
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 11, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). A 3I T3 WITH DCD TAPERED IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED NO SIGN OF DAMAGE WITHIN THE EXTERNAL THREADS OF THE IMPLANT. THE INTERNAL HEX OF THE IMPLANT WAS IN GOOD CONDITION AND SHOWED NO SIGNS OF DAMAGE. VISUAL AND DIMENSIONAL COMPARISON OF THE IMPLANT WITH ITS SPECIFICATION DRAWING (DWG NO. 1040010 REV. C) VERIFIED THAT THE IMPLANT WAS CONSISTENT WITH THE DESIGN AND WITHIN ALL REQUIRED SPECIFICATIONS. THE PATIENT WAS ALSO REPORTED TO HAVE EDEMA AND INFLAMMATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: BIOMET 3I DENTAL IMPLANT IFU (P-IIS086GI) REV F - (B)(6) 2015. INFORMATION IDENTIFIED: WARNINGS, POTENTIAL ADVERSE EVENTS. COMPLAINANT REPORTED PAIN AND SENSITIVITY AROUND THE GINGIVA OF IMPLANT. THE REPORTED EVENT COULD NOT BE VERIFIED, AS THE EXACT DETAILS OF DEVICE USAGE AND THE PATIENT¿S ANATOMICAL CONDITIONS WERE UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PAIN AND SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530485 3I T3® WITH DCD® TAPERED IMPLANT 5/4 X 10MM IMPLANT DZE BIOMET 3I 2017020634

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention