BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 5.0X8.5MM

    MDR report key: 10588914 · Received September 25, 2020

    Report

    Report Number
    9611993-2020-40310
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    July 16, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K083205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTGRATE. (B)(4). RECEIVED DATE OF THE RETURN PRODUCT: 25/09/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053479 NOBELACTIVE INTERNAL RP 5.0X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention