BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSX IMPLANT, 4.1MMD, 11.5MML

    MDR report key: 24866119 · Received April 13, 2026

    Report

    Report Number
    0001038806-2026-02004
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868045106
    PMA / PMN Number
    K220978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: PATIENT SEX UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS 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 BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NON-EXISTENT. 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 WAS PLACED AT TOOTH SITE #6 AS AN IMMEDIATE WITH GRAFT AND MEMBRANE. AT THE POST-OPERATIVE APPOINTMENT, THERE WAS SWELLING PRESENT AND A FOLLOW UP CT SCAN NOTED BONE LOSS AROUND THE BUCCAL PLATE. THE IMPLANT WAS REMOVED AND GRAFT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252667 TSX IMPLANT, 4.1MMD, 11.5MML DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2120015660 00844868045106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention