BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8846099 · Received July 31, 2019

    Report

    Report Number
    0001038806-2019-00794
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    June 11, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN OSSEOTITE IMPLANT (BOST510) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE WITHIN THE EXTERNAL THREADS OF THE IMPLANT. THE INTERNAL HEX AND COLLAR OF THE IMPLANT WERE IN GOOD CONDITION AND SHOWED SIGNS OF MINOR USE. VISUAL AND DIMENSIONAL COMPARISON OF THE IMPLANT WITH THE DRAWING (DWG NO. 1040025 REV. B) USING A CALIPER (CAL1334; CALIBRATION DUE: 25-SEP-2020) VERIFIED THAT THE IMPLANT WAS CONSISTENT WITH THE DESIGN. THE IMPLANT WAS LOCATED AT TOOTH #19 AND WAS IMPLANTED FOR APPROXIMATELY 3 YEARS. THE PATIENT WAS REPORTED TO HAVE LOW DENSITY BONE. THE PATIENT ALSO HAD SEVERAL PATIENT IMPACTS (ABSCESS, INFLAMMATION, PAIN) AS A CONSEQUENCE OF THE INFECTION AND BONE LOSS. NO OTHER PRE-EXISTING PATIENT CONDITIONS WERE NOTED ON THE PER OR IN THE COMPLAINT. NO X-RAY IMAGES WERE PROVIDED FOR THE REPORTED EVENTS OF BONE LOSS AND INFECTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2013111043). 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 EVENTS WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP#210) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2013111043) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION/BONE LOSS) OR FOR THE REPORTED DEVICE (BOST510). BASED ON THE INVESTIGATION, THE IMPLANT DID NOT MALFUNCTION. THE REPORTED EVENTS (INFECTION, BONE LOSS) ARE NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION EVENTS. 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. DEVICE EVALUATED BY MANUFACTURER. MANUFACTURER DATE. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PERIIMPLANTITIS, ABSCESS, INFLAMMATION , AND PAIN. AS A RESULT, THE IMPLANT (BOST510) WAS REMOVED. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639223 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2013111043

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention