BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, Ø 4.1MM RC, SLACTIVE 10MM, TIZR, NTP

    MDR report key: 13525363 · Received February 14, 2022

    Report

    Report Number
    0001222315-2022-02542
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 14, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706850
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 19. ON (B)96) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262985 BL, Ø 4.1MM RC, SLACTIVE 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL FWM64 07630031706850

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention