BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 21816643 · Received April 10, 2025

    Report

    Report Number
    MW5168826
    Event Type
    Injury
    Date Received
    April 10, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BIOMET 3I, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FAILED TO OSSEOINTEGRATE INFECTION, FISTULA AND SWELLING. WAS PROSTHESIS FITTED, NO. SITE 3. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092743 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOMET 3I, LLC T3PT6510

    Patients

    Seq Age Sex Outcome Treatment
    1 Female