BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® TAPERED IMPLANT 6/5 X 13MM

    MDR report key: 9972250 · Received April 17, 2020

    Report

    Report Number
    0001038806-2020-00700
    Event Type
    Injury
    Date Received
    April 17, 2020
    Date of Event
    March 16, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® TAPERED IMPLANT 6/5 X 13MM (BOPT6513) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED DRIED 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 1334, SEPT 25 2020) AND WAS VERIFIED TO MATCH SPECIFICATIONS PER DWG. NO. 1040011 REV C. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE PATIENT HAD MODERATE (TYPE II) BONE DENSITY. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 19 AND WAS IMPLANTED FOR 4 DAYS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED NUMBING ON LOWER RIGHT LIP AND THEY HAD TO REMOVE IMPLANT SINCE IT WAS PUTTING PRESSURE ON THE IAN (INFERIOR ALVEOLAR NERVE). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2018100373). 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, 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 (2018100373) 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 (BOPT6513). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS CLINICIAN TREATMENT PLANS AND PLACES IMPLANT THAT IS LONGER THAN THE BONE VOLUME (LENGTH) CAN ACCEPT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (BOPT6513) WAS REMOVED DUE TO IMPLANT WAS PUTTING PRESSURE ON THE INFERIOR ALVEOLAR NERVE. PATIENT EXPERIENCE NUMBING ON THE LOWER RIGHT LIP. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437811 3I T3® TAPERED IMPLANT 6/5 X 13MM DENTAL IMPLANT DZE BIOMET 3I 2018100373

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention