BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MMRC SLACTIVE10MM ROXOLID LOXIM

    MDR report key: 9498833 · Received December 19, 2019

    Report

    Report Number
    0009613348-2019-52177
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 19, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707031
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289716 BLT Ø4.1MMRC SLACTIVE10MM ROXOLID LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG VC197 07630031707031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention