BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT STRAIGHT TIU 3MMNP 3.5X13

    MDR report key: 19522914 · Received June 12, 2024

    Report

    Report Number
    2027971-2024-090914
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 12, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION (B)(6) 2024 13:27:40 CET (5001035) OSTEOMYELITIS WAS SELECTED AS A CONDITION INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372495 REPLACE SELECT STRAIGHT TIU 3MMNP 3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention