BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC NP 3.5X10MM

    MDR report key: 11961833 · Received June 8, 2021

    Report

    Report Number
    2027971-2021-79745
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 26, 2021
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747035766
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855048 NOBELREPLACE CC NP 3.5X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13097270 7332747035766

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention