BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLAN

    MDR report key: 2833085 · Received November 6, 2012

    Report

    Report Number
    1057129-2012-00006
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 5, 2012
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER INFO WAS NOT PROVIDED TO ENABLE AN INVESTIGATION OF THE DEVICE HISTORY FILES.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PT RECEIVED A MEDPOR TWO-PIECE CHIN AND RAMUS W/INF. RIDGE LANE LEFT AND RIGHT IMPLANTS. AT FOUR WEEKS, EVERYTHING LOOKED GOOD, THEN AT APPROXIMATELY FIVE WEEKS THE PT RETURNED WITH SWELLING AND DRAINAGE. THE DOCTOR STARTED ORAL ANTIBIOTIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other