BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRÅNEMARK SYSTEM MK III TIU RP 3.75X10MM

    MDR report key: 20571659 · Received October 30, 2024

    Report

    Report Number
    2027971-2024-138064
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 21, 2024
    Report Date
    October 30, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747001174
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY. 30.10.2024 15:34:00 CET (5020889) IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY OF PROSTHETIC RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982061 BRÅNEMARK SYSTEM MK III TIU RP 3.75X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12128055 07332747001174

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention