BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® WITH DCD® TAPERED IMPLANT 4/3 X 8.5MM

    MDR report key: 15405682 · Received September 12, 2022

    Report

    Report Number
    0001038806-2022-01413
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    May 24, 2022
    Report Date
    February 20, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868028352
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2022-01411. (B)(4). WEIGHT UNKNOWN/NOT PROVIDED. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2023-01411-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. ONE (1) 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 8.5MM (BNPT4385) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. MEASUREMENTS MATCHED DRAWING. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THERE IS NO EXISTING ACTIONABLE TREND OR NON-CONFORMANCE / CAPA / HHE / D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (2021020712). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE'S, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. THE LOT NUMBER WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORDS (OP#0210) WERE REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (2021020712) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE DEVICES COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE/MEDICAL EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. THE COMPLAINT IS NOT RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED ARE INADEQUATE TREATMENT PLANNING AND PATIENT FACTORS. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #19 AND #20 WERE REMOVED DUE TO NERVE DAMAGE. SYMPTOMS OF THE EVENT: PARESTHESIA AND NUMBNESS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THIS TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970341 3I T3® WITH DCD® TAPERED IMPLANT 4/3 X 8.5MM DENTAL IMPLANT DZE BIOMET 3I BNPT4385 2021020712 00844868028352

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention