BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 19480200 · Received June 5, 2024

    Report

    Report Number
    MW5155860
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BIOMET 3I, LLC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING CLINICAL PROCEDURE, FAILURE TO INTEGRATE. TOOTH NUMBER 29, BONE DENSITY TYPE: UNK. 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
    1258230 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOMET 3I, LLC. BOPT5410 2023020096

    Patients

    Seq Age Sex Outcome Treatment
    1 Female