BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP

    MDR report key: 13525403 · Received February 14, 2022

    Report

    Report Number
    0001222315-2022-02600
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    November 25, 2021
    Report Date
    February 14, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707031
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B0(6) 20226 IN ADA 29. ON 2021-11-25, 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
    1262994 BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL CZL49 07630031707031

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention