BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 2110480 · Received June 1, 2011

    Report

    Report Number
    1057129-2011-00012
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED AND ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HE RECEIVED A MEDPOR RIGHT SMALL DESIGN M MALAR IN (B)(6) 2010. THE PATIENT STATED THAT HE HAS AN INFECTION CALLED (B)(6). THE PATIENT STATED THAT HE HAS HAD THIS INFECTION OVER SEVERAL MONTHS. THE PATIENT STATED THAT A PART OF THE IMPLANT IS EXPOSED AND "GETS WASHED" WITH POLY HEXAMID, SERASEPT 0.04% ON A DAILY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT FWP STRYKER CRANIOMAXILLOFACIAL GEORGIA NA F038B02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other