BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLX Ø5.5 WB, SLACTIVE® 8MM, RXD

    MDR report key: 19004766 · Received March 29, 2024

    Report

    Report Number
    0001222315-2024-000783
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 28, 2024
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031736635
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2023-10-10 IN ADA 14. ON 2024-01-26, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583655 BLX Ø5.5 WB, SLACTIVE® 8MM, RXD ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TGR52 07630031736635

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention