BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLACTIVE® 12MM, TIZR, NTP

    MDR report key: 9300809 · Received November 8, 2019

    Report

    Report Number
    0009613348-2019-42034
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    October 8, 2019
    Report Date
    November 8, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706638
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN FDI 21. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH PREVIOUS BONE AUGMENTATION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095192 BLT Ø3.3MM NC, SLACTIVE® 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG PC402 07630031706638

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention