BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8983171 · Received September 10, 2019

    Report

    Report Number
    0001222315-2019-01281
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    March 28, 2019
    Report Date
    September 9, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707031
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT EXPERIENCED THE FOLLOWING AT THE TIME OF EVENT: INFECTION, PAIN, MOBILITY AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778934 BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TZ041 07630031707031

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention