BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1831960 · Received September 8, 2010

    Report

    Report Number
    1057129-2010-00030
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 7, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOT NUMBER 89020-MCI-319-10 (B)(4) WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPEC. .

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PT HAD A GLIOMA RESECTION TO REMOVE A TUMOR AND HAD RADIO THERAPY SESSIONS FOLLOWING THE PROCEDURE. THE DOCTOR STATED THAT DURING THE RADIO THERAPY SESSIONS, THE WOUND WAS PULLED OPEN WHILE REMOVING AN INDICATOR. THE DOCTOR REPORTED THAT A LOCAL INFECTION PRESENTED AT THE WOUND SITE AND WAS TREATED WITH ANTIBIOTICS. THE DOCTOR STATED THAT THREE WEEKS LATER ON (B)(6) 2010, THE PT RECEIVED A MEDPOR CUSTOMIZED RIGHT CRANIAL IMPLANT TO CORRECT THE DEFECT. THE DOCTOR STATED THAT PT RETURNED ON (B)(6) 2010, WITH A SKIN INFECTION THAT IS PRODUCING FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR CUSTOMIZED SURGICAL IMPLANT FTM POREX SURGICAL NA MCI-31910 F002F67H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other