BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1589358 · Received January 25, 2010

    Report

    Report Number
    1057129-2010-00003
    Event Type
    Injury
    Date Received
    January 25, 2010
    Date of Event
    September 4, 2009
    Report Date
    January 25, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    GXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER 89020-MCI-337-09-E007G78H, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PATIENT RECEIVED A MEDPOR CRANIAL IMPLANT. THE DOCTOR REPORTED THAT THE PT DEVELOPED AN INFECTION AND THE IMPLANT WAS REMOVED. THE DOCTOR STATED THAT HE TREATED THE INFECTION WITH ANTIBIOTICS. THE DOCTOR STATED THAT THE CURRENT CONDITION OF THE PT IS GOOD. THE DOCTOR IS PLANNING TO PLACE ANOTHER MEDPOR CRANIAL IMPLANT IN (B) (6) OF 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION GXN POREX SURGICAL NA MCI-337-09E007G78H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other