BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLX Ø5.0 WB, SLACTIVE® 8MM, RXD

    MDR report key: 18642256 · Received February 5, 2024

    Report

    Report Number
    0001222315-2024-002769
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    October 25, 2023
    Report Date
    February 5, 2024
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031743725
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 20. ON 2023-10-25, 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
    2079759 BLX Ø5.0 WB, SLACTIVE® 8MM, RXD ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG PZX29 07630031743725

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention