BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM

    MDR report key: 9035793 · Received September 13, 2019

    Report

    Report Number
    0001038806-2019-01064
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    July 18, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM (IFNT511) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FOREIGN MATERIAL AROUND THE BOTTOM OF THE IMPLANT. NO DAMAGE IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THE RETURNED DEVICE WAS MEASURED WITH A CALIPER (CAL4063 CAL DUE: NOV 20, 2019) AND VERIFIED TO MATCH DHR SPECIFICATIONS PER DWG NO. 223411 REV N. PRE-EXISTING CONDITION NOTED ON THE PER IS DIABETES. THE REPORTED DEVICE WAS LOCATED ON TOOTH #6 AND WAS USED FOR APPROXIMATELY 2 YEARS, 7 MONTHS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2016060240). 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2016060240) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT BONE LOSS, AND DEVICE (IFNT511). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (IFNT511) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820629 FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2016060240

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention