BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CONTAIN SHEET 25MM X 30

    MDR report key: 3062037 · Received April 16, 2013

    Report

    Report Number
    0008010177-2013-00065
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    STRYKER CMF-GEORGIA
    Product Code
    NPK
    PMA / PMN Number
    K091120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    SURGEON REMOVED MEDPOR CONTAIN IMPLANT FROM 4 PATIENTS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163516 MEDPOR CONTAIN SHEET 25MM X 30 IMPLANT NPK STRYKER CMF-GEORGIA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1