BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 11.5MM

    MDR report key: 9597587 · Received January 16, 2020

    Report

    Report Number
    0001038806-2020-00142
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 2, 2019
    Report Date
    March 5, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 11.5MM (BNSS411) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE REPORTED PRODUCT IDENTIFIED MINOR SIGNS OF USE AROUND THE EXTERNAL THREADS FROM TREPHINE REMOVAL. THERE WAS PRESENCE OF BONE RESIDUE AND DRIED BLOOD AROUND THE EXTERNAL THREADS AND THE CUTTING EDGES. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENTS. THE REPORTED DEVICE WAS MEASURED WITH CALIPERS (CAL1831 CAL DUE: (B)(6) 2020) AND WAS VERIFIED TO MATCH SPECIFICATIONS PER DWG. NO. 1040016 REV D. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER, THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 30 AND WAS USED FOR APPROXIMATELY 1 YEAR. THE CUSTOMER PROVIDED AN X-RAY IMAGE. SME EVALUATION OF THE X-RAY, BY THE MEDICAL AFFAIRS MANAGER WAS ABLE TO CONFIRM THE BONE LOSS EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2018061673). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, 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. STERILIZATION RECORD (OP210) 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 (2018061673) FOR SIMILAR EVENTS AND NO OTHER RELATIVE COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION & BONE LOSS) OR DEVICE (BNSS411). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED INFECTION WAS NON-VERIFIABLE WHILE THE REPORTED BONE LOSS WAS CONFIRMED WITH SME EVALUATION OF THE PROVIDED X-RAY. IN ADDITION, INFECTION AND BONE LOSS ARE LISTED AS A HARM OR POTENTIAL EFFECT OF IMPLANT FAILURE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    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). PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (BNSS411) WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59077 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2018061673

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention