BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC RP 4.3X8MM

    MDR report key: 19932450 · Received August 7, 2024

    Report

    Report Number
    2027971-2024-109663
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    August 14, 2023
    Report Date
    August 7, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560590 NOBELREPLACE CC PMC RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention