BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17790496 · Received September 21, 2023

    Report

    Report Number
    0001222315-2023-023162
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707031
    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 (B)96) 2022 IN ADA 29. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY, SWELLING, BLEEDING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445839 BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG LVF74 07630031707031

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention