BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT 3.3MM NC, SLACTIVE 10MM, TIZR, NTP

    MDR report key: 11833460 · Received May 17, 2021

    Report

    Report Number
    0001222315-2021-07960
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    February 23, 2021
    Report Date
    May 17, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706621
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2020-10-27 IN ADA 3. ON 2021-02-23, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. 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
    732138 BLT 3.3MM NC, SLACTIVE 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL CJC38 07630031706621

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention