BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12180907 · Received July 16, 2021

    Report

    Report Number
    0001038806-2021-01294
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    April 19, 2021
    Report Date
    November 12, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868029656
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2021-01295-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2018041456). 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 ((B)(6)) 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 (2018041456) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2021-01295. ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DOCTOR INDICATED THAT AFTER IMPLANT PLACEMENT, INFECTION OCCURRED AND THE FIXTURES WERE REMOVED. TOOTH SITES UL6-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081016 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I BOST510 2018041456 00844868029656

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention