BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CUSTOMIZED MIDFACE

    MDR report key: 3831644 · Received May 26, 2014

    Report

    Report Number
    0008010177-2014-00138
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    PMA / PMN Number
    K121315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS KEPT BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DOCTOR KEPT THE DEVICE.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON OF A REVISION OF A MALAR IMPLANT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309928 MEDPOR CUSTOMIZED MIDFACE IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN K09087DC11SEP

    Patients

    Seq Age Sex Outcome Treatment
    1