BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC NP 3.75X15MM

    MDR report key: 10496756 · Received September 4, 2020

    Report

    Report Number
    9611993-2020-36732
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    January 18, 2019
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747091472
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION. 04.09.2020 21:03:41 (B)(6). USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT: 04/09/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960333 NOBELPARALLEL CC NP 3.75X15MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12096801 7332747091472

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention