BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD IMPLT 5D X 12MM TPS/HL

    MDR report key: 16780461 · Received April 20, 2023

    Report

    Report Number
    9611993-2023-060141
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    September 5, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K925555
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    1590327 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