BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 13MM (L)

    MDR report key: 19510159 · Received June 11, 2024

    Report

    Report Number
    0001038806-2024-01219
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    March 27, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868046882
    PMA / PMN Number
    K213672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). MULTIPLE REPORTS ARE BEING SUBMITTED FOR THIS EVENT. 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. H3 OTHER TEXT : SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. USED IMPLANT CONCIERGE STENT. TOOTH #5, 12 (UNIVERSAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078662 T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 13MM (L) DENTAL IMPLANT DZE BIOMET 3I 2023060377 00844868046882

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention