BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    MDR report key: 11690483 · Received April 19, 2021

    Report

    Report Number
    2027971-2021-62270
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    August 8, 2019
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747017953
    PMA / PMN Number
    K083205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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
    585727 NOBELACTIVE INTERNAL RP 4.3X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13083422 7332747017953

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention