BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANT

    MDR report key: 12556431 · Received September 30, 2021

    Report

    Report Number
    9611993-2021-095212
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    July 27, 2021
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(4) RECEIVED DATE OF THE RETURN PRODUCT:30/09/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450933 UNKNOWN IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention