BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD IMPLT 5D X 12MM TPS/HL

    MDR report key: 16780567 · Received April 20, 2023

    Report

    Report Number
    2027971-2023-066349
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    September 5, 2022
    Report Date
    April 20, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591300 THD IMPLT 5D X 12MM TPS/HL ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention