BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S, Ø 4.1 MM, RN , SLA 10.0 MM

    MDR report key: 9043506 · Received September 13, 2019

    Report

    Report Number
    0009613348-2019-22172
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    February 14, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031718334
    PMA / PMN Number
    K983742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN THE PATIENT'S MOUTH. ON (B)96) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. 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
    845266 S, Ø 4.1 MM, RN , SLA 10.0 MM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG 07630031718334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention