BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLA® 12MM, TIZR, LOXIM

    MDR report key: 18248926 · Received December 1, 2023

    Report

    Report Number
    0001222315-2023-029892
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 14, 2022
    Report Date
    December 1, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706737
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 9. ON 2022-11-14, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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
    1429904 BLT Ø3.3MM NC, SLA® 12MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG JVR55 07630031706737

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention