BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, 4.1MM RC, SLACTIVE 12MM, TIZR, NTP

    MDR report key: 11762025 · Received May 3, 2021

    Report

    Report Number
    0001222315-2021-07125
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    February 24, 2021
    Report Date
    May 3, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706874
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2020-10-07 IN ADA 8. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, 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
    659556 BL, 4.1MM RC, SLACTIVE 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL CJG99 07630031706874

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention