BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L)

    MDR report key: 8880692 · Received August 9, 2019

    Report

    Report Number
    0001038806-2019-00856
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    April 30, 2019
    Report Date
    November 11, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K150571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L) (BOES505) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND EXTERNAL DRIVE FEATURE. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 1173001 REV B. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON AN UNKNOWN TOOTH SITE AND USED FOR APPROXIMATELY 19 DAYS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2017051667. 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. STERILIZATION RECORD (OP150) 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 (2017051667) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION + BONE LOSS) OR PRODUCT (BOES505). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (BOES505) WAS REMOVED DUE TO PERIIMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674785 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L) DENTAL IMPLANT DZE BIOMET 3I 2017051667

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention