BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9275354 · Received November 4, 2019

    Report

    Report Number
    0009613348-2019-40249
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    June 3, 2019
    Report Date
    November 4, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707444
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)96) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070065 BLT Ø4.8MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TK639 07630031707444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention