BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC RP 5.0X11.5MM

    MDR report key: 19037325 · Received April 3, 2024

    Report

    Report Number
    9611993-2024-059156
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 7, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    1545097 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