BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRNEMARK SYSTEM MK III TIU RP 3.75X10MM

    MDR report key: 10503677 · Received September 8, 2020

    Report

    Report Number
    2027971-2020-33252
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 8, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747001174
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM. 08.09.2020 17:55:03 CET (B)(6). USER: ESEVBE RECEIVED DATE OF THE RETURN PRODUCT: 07/09/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968074 BRNEMARK SYSTEM MK III TIU RP 3.75X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12100988 7332747001174

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention