BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM

    MDR report key: 15543215 · Received October 5, 2022

    Report

    Report Number
    0001038806-2022-01505
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868028888
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT CMP-0841560. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN OFFICE WITH IMPLANT IN HAND. INFECTION, PAIN, ABSCESS, EDEMA AND INFLAMMATION ARE REPORTED. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR TO AND TOGETHER WITH THE ORIGINAL IMPLANT PLACEMENT. TOOTH SITE # 5 (UNIVERSAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556134 3I T3¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I BOST3211 2021101351 00844868028888

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention