BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SU-POR SURGICAL IMPLANTS

    MDR report key: 12033989 · Received June 21, 2021

    Report

    Report Number
    3010781616-2021-00082
    Event Type
    Injury
    Date Received
    June 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    PORIFEROUS, LLC
    Product Code
    KKY
    UDI-DI
    00815285020069
    PMA / PMN Number
    K140437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A PATIENT REQUIRED SECONDARY SURGERY DUE TO SWELLING (ADEMA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932083 SU-POR SURGICAL IMPLANTS CRAN IOMAXILLOFACIAL IMPLANT KKY PORIFEROUS, LLC 4006 00815285020069

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R