BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MM RC, SLA® 8MM, TIZR, LOXIM

    MDR report key: 17663631 · Received August 31, 2023

    Report

    Report Number
    0001222315-2023-021287
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    April 7, 2023
    Report Date
    August 31, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707123
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022-11-18 IN ADA 4. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2023, 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
    1602641 BLT Ø4.1MM RC, SLA® 8MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG KNV55 07630031707123

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention