BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD IMPLT 5D X 12MM TI/HL

    MDR report key: 16419508 · Received February 22, 2023

    Report

    Report Number
    2027971-2023-044235
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 27, 2023
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    PMA / PMN Number
    K925481
    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 OSSEOINTEGRATION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676953 THD IMPLT 5D X 12MM TI/HL ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 954946

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention