BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLX Ø5.0 WB, SLACTIVE® 10MM, RXD

    MDR report key: 18420025 · Received December 29, 2023

    Report

    Report Number
    0001222315-2023-032243
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    November 15, 2022
    Report Date
    December 29, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031743732
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 3. DETAILS OF SURGERY: SINUS AUGMENTATION. ON 2022-11-15, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665634 BLX Ø5.0 WB, SLACTIVE® 10MM, RXD ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG KPP77 07630031743732

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention