BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC RP 5.0X11.5MM

    MDR report key: 19037117 · Received April 3, 2024

    Report

    Report Number
    2027971-2024-064093
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 3, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. 03.04.2024 15:15:10 CET (5023852). USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:03/04/2024/

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624639 NOBELREPLACE CC RP 5.0X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention