BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1060874 · Received June 13, 2008

    Report

    Report Number
    1057129-2008-00021
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 19, 2008
    Report Date
    June 12, 2008
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 81027-0162001204H, 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 THE PT HAD AN ORBITAL BLOWOUT FRACTURE RECONSTRUCTED APPROX. TWO AND ONE HALF YEARS AGO BY ANOTHER SURGEON AND RECEIVED A MEDPOR TITAN BARRIER IMPLANT. THE DOCTOR STATED THAT THE PT RECENTLY WOKE UP WITH HYPERGLOBUS AND POSSIBLY DIPLOPIA WITH RESTRICTION OF MOTILITY IN THE AFFECTED ORBIT. THE DOCTOR STATED THAT THE PT HAD A HEMATIC CYST IN THE AREA OF THE MEDPOR IMPLANT. THE DOCTOR REPORTED THAT IN 2008 HE PERFORMED SURGERY FOR DRAINAGE AND EXCISION OF THE HEMATIC CYST AND REMOVED THE MEDPOR IMPLANT. THE DOCTOR STATED THAT HE PLACED A NON-MEDPOR IMPLANT AND THE PT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION FTL POREX SURGICAL, INC. NA 0162001204H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other