BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSX¿ IMPLANT, 3.1MMD, 10MML

    MDR report key: 23659008 · Received November 26, 2025

    Report

    Report Number
    0001038806-2025-03429
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868044994
    PMA / PMN Number
    K220978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 31 WAS REMOVED DUE TO A PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673091 TSX¿ IMPLANT, 3.1MMD, 10MML DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1269082 00844868044994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention