BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRÅNEMARK SYSTEM MK III TIU RP 3.75X13MM

    MDR report key: 10171060 · Received June 18, 2020

    Report

    Report Number
    9611993-2020-25555
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K022562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION. (B)(6) 2020 11:55:19 CET (B)(6). USER:ESEVBE RECEIVED DATE OF THE RETURN PRODUCT:(B)(6) 2020. (B)(6) 2020 11:55:42 CET (B)(6). USER:ESEVBE RECEIVED DATE OF THE RETURN PRODUCT:(B)(6) 2020. (B)(6) 2020 11:56:11 CET (B)(6). USER:ESEVBE RECEIVED DATE OF THE RETURN PRODUCT:(B)(6) 2020. (B)(6) 2020 12:40:04 CET (B)(6). USER:ESEVBE RECEIVED DATE OF THE RETURN PRODUCT:(B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634880 BRÅNEMARK SYSTEM MK III TIU RP 3.75X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 663313

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention