BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.8MM RC, SLACTIVE® 10MM, TIZR, NTP

    MDR report key: 18216144 · Received November 28, 2023

    Report

    Report Number
    0001222315-2023-029596
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 27, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707444
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 18. ON 2023-10-16, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600087 BLT Ø4.8MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG GEH46 07630031707444

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention