BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø2.9MM SC, SLACTIVE® 10MM, RXD, LOXI

    MDR report key: 15251731 · Received August 18, 2022

    Report

    Report Number
    0001222315-2022-17259
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 18, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031728005
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NH, 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 20. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)96) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, INADEQUATE BONE QUALITY/QUANTITY AND PREVIOUS BONE AUGMENTATION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, SWELLING, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461416 BLT Ø2.9MM SC, SLACTIVE® 10MM, RXD, LOXI ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL HGK66 07630031728005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention