BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 852664 · Received May 18, 2007

    Report

    Report Number
    1057129-2007-00007
    Event Type
    Injury
    Date Received
    May 18, 2007
    Date of Event
    March 12, 2007
    Report Date
    May 15, 2007
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER A477E11A, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION. WE HAVE HAD TWO INCIDENCES CONCERNING EXPOSED EAR RIM IMPLANTS. THE MDR REPORTING NUMBERS ARE 1057129-2006-0014 AND 1057129-2007-0001.

    Description of Event or Problem · 1

    THE PATIENT HAD EAR RECONSTRUCTION SURGERY PERFORMED ON THE LEFT EAR USING A MEDPOR EAR IMPLANT. DURING THE SURGERY, THE MEDPOR EAR IMPLANT WAS COVERED WITH TPF FLAP AND SKIN GRAFT. THE SURGEON REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE SURGERY, A MINOR TRAUMA OCCURRED AND A PORTION OF THE IMPLANT BECAME EXPOSED AND THE TISSUE SURROUNDING THE IMPLANT BECAME NECROTIC. THE SURGEON STATED THAT HE EXPLANTED A PORTION OF THE MEDPOR EAR RIM IMPLANT. THE EXPLANTED PORTION OF THE IMPLANT WAS EVALUATED BY A LABORATORY PER THE SURGEON AND THE RESULT WAS FOREIGN BODY REACTION WITH NO INDICATION OF INFECTION. THE SURGEON PLACED COMPOSITE GRAFT AT THE DEFECT SITE TO REPLACE THE PORTION OF THE MEDPOR IMPLANT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL, INC. NA A477E11A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other