BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC RP 4.3X8MM

    MDR report key: 19921940 · Received August 6, 2024

    Report

    Report Number
    9611993-2024-096509
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 29, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160703
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573048 NOBELREPLACE CC PMC RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 13101356 07332747160703

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention