BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT

    MDR report key: 2625052 · Received June 21, 2012

    Report

    Report Number
    1057129-2012-00004
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    October 22, 2010
    Report Date
    June 21, 2012
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR (B)(4) WAS CONDUCTED AND ALL SPECIFICATION AND TEST CRITERIA WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE STRYKER SALES REPRESENTATIVE THAT THE PATIENT WAS HAVING SLIGHT POST OPERATIVE "COMPLICATIONS" SUCH AS IRRITATION. THE SURGEON REPORTED THAT THE IMPLANT WAS REMOVED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT IMPLANT FWP STRYKER CRANIOMAXILLOFACIAL GEORGIA NA C052B04

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other