BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 13MM

    MDR report key: 9902676 · Received March 31, 2020

    Report

    Report Number
    0001038806-2020-00595
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    March 2, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 13MM (BOST513) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED DRIED BLOOD AND BONE, SIGNS OF USE AND NO APPARENT MALFUNCTION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THE RETURNED DEVICE WAS MEASURED WITH CALIPERS (CAL 1831, SEPT 25 2020) AND WAS VERIFIED TO MATCH SPECIFICATIONS PER DWG. NO. 1040025 REV C. A PRE-EXISTING CONDITION NOTED ON THE PER WAS DIABETES. ADDITIONALLY, THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 28 AND WAS IMPLANTED FOR LESS THAN 3 WEEKS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED TWITCHING OF THE FACE AFTER IMPLANT WAS PLACED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2018120613). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. ALTHOUGH NC 6457524-1 WAS IDENTIFIED, IT WAS DETERMINED THERE WAS NO NEGATIVE IMPACT ON REGULATORY REQUIREMENTS, PRODUCT SAFETY OR FUNCTIONALITY AND NO IE OR CAPA WAS CREATED. THEREFORE, NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2018120613) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MEDICAL: OTHER) OR PRODUCT (BOST513). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (BOST513) WAS REMOVED. PATIENT DEMANDED THE IMPLANT TO BE REMOVED AFTER EXPERIENCE A NERVE TWITCHING SENSATION NEAR THE SURGICAL SITE AFTER PLACEMENT. TOOTH LOCATION 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367451 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 13MM DENTAL IMPLANT DZE BIOMET 3I 2018120613

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention