BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 5.0X10MM

    MDR report key: 11904203 · Received May 28, 2021

    Report

    Report Number
    2027971-2021-75923
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 21, 2021
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747010664
    PMA / PMN Number
    K071370
    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 LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800592 NOBELACTIVE INTERNAL RP 5.0X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13089353 7332747010664

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention