BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLACTIVE® 14MM, TIZR, NTP

    MDR report key: 13119867 · Received December 30, 2021

    Report

    Report Number
    0001222315-2021-23021
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 30, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706645
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2021-07-15 IN ADA 11. ON 2021-11-08, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018030 BLT Ø3.3MM NC, SLACTIVE® 14MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL FNL04 07630031706645

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention