BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC RP 4.3X13MM

    MDR report key: 19766444 · Received July 17, 2024

    Report

    Report Number
    2027971-2024-102736
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    May 16, 2024
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    07332747160734
    PMA / PMN Number
    K062566
    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
    2040905 NOBELREPLACE CC PMC RP 4.3X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13165633 07332747160734

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention