BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.8MM RC, SLA® 8MM, TIZR, LOXIM

    MDR report key: 17004557 · Received May 25, 2023

    Report

    Report Number
    0001222315-2023-012808
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 25, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707536
    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 2022-11-17 IN ADA 2. ON 2023-03-28, 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
    1619291 BLT Ø4.8MM RC, SLA® 8MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Roxolid BL NJM40 07630031707536

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention