BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLA® 14MM, TIZR, LOXIM

    MDR report key: 13472921 · Received February 7, 2022

    Report

    Report Number
    0001222315-2022-02227
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    July 29, 2021
    Report Date
    February 7, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706744
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2021-07-06 IN ADA 10. ON 2021-07-29, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447579 BLT Ø3.3MM NC, SLA® 14MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Roxolid BL EMX59 07630031706744

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention