BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® TAPERED IMPLANT 4/3 X 11.5MM

    MDR report key: 22056859 · Received May 20, 2025

    Report

    Report Number
    0001038806-2025-01136
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868028475
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K122300. 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 IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12601 3I T3® TAPERED IMPLANT 4/3 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2120005627 00844868028475

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention