BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 6MM (D) X 13MM (L)

    MDR report key: 16315308 · Received February 7, 2023

    Report

    Report Number
    0001038806-2023-00237
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 23, 2023
    Report Date
    May 17, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868047032
    PMA / PMN Number
    K213672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: THE DEVICE EXPIRATION DATE HAS BEEN UPDATED/CORRECTED FROM APRIL 19, 2024 TO APRIL 19, 2027.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. 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

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING CHRONIC INFECTION SINCE THE IMPLANT AT TOOTH LOCATION #30 WAS PLACED. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126588 T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 6MM (D) X 13MM (L) DENTAL IMPLANT DZE BIOMET 3I T3ST613 2022030600 00844868047032

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention