BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC RP 4.3X8MM

    MDR report key: 19966185 · Received August 12, 2024

    Report

    Report Number
    2027971-2024-111077
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    May 15, 2024
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    07332747160703
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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
    2200860 NOBELREPLACE CC PMC RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13160849 07332747160703

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention