BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1618145 · Received February 25, 2010

    Report

    Report Number
    1057129-2010-00004
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 24, 2010
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    GXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBER: MCI-414-09-E021J95H. FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER 89020-MCI-414-09-E020J95H AND 89020-MCI-414-09-E021J95H IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION. CONTRAINDICATIONS LISTED IN THE MEDPOR INSTRUCTIONS FOR USE STATE THAT "TISSUE IRRADIATED IN CANCER THERAPY HAS BEEN COMPROMISED, USING MEDPOR IMPLANTS IN THESE AREAS MAY BE PROBLEMATIC." THIS INSTRUCTIONS FOR USE ACCOMPANIES EACH MEDPOR IMPLANT SOLD INTO COMMERCE.

    Description of Event or Problem · 1

    THE PHYSICIAN ASSISTANT STATED THAT THE PT RECEIVED A MEDPOR CRANIAL IMPLANT IN (B) (6) OF 2009. THE PHYSICIAN ASSISTANT STATED THAT "THE PT DID NOT START RADIATION, BUT RATHER ORAL THALIDOMIDE AND DEXAMETHASONE AT TWO WEEKS POST CRANIAL IMPLANT AND CONTINUES TO TAKE THESE MEDICATIONS". THE PA REPORTED THAT THE PT DEVELOPED AN INFECTION AND THE IMPLANT WAS REMOVED IN (B) (6) OF 2010. THE PA STATED THAT THE IMPLANT WAS SENT TO A LABORATORY AND THE FINDINGS WAS "STAPH AUREUS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION GXN POREX SURGICAL, INC. NA MCI-414-09-E020J95H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other