BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MM RC, SLACTIVE® 12MM, TIZR, NTP

    MDR report key: 9498783 · Received December 19, 2019

    Report

    Report Number
    0001222315-2019-14524
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    October 19, 2019
    Report Date
    December 19, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707048
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN ADA 14. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY AND PREVIOUS BONE AUGMENTATION. 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
    1289700 BLT Ø4.1MM RC, SLACTIVE® 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG PP295 07630031707048

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention