BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP, Ø4.8MM WN, SLA 10MM

    MDR report key: 9598652 · Received January 16, 2020

    Report

    Report Number
    0009613348-2020-03234
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    May 14, 2019
    Report Date
    January 16, 2020
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719195
    PMA / PMN Number
    K033922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59166 SP, Ø4.8MM WN, SLA 10MM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG PC887 07630031719195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention