BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1657158 · Received April 9, 2010

    Report

    Report Number
    1057129-2010-00008
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    July 1, 2008
    Report Date
    April 8, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL HOWEVER; FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 9569-D003D55H, 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 "MEDPOR IMPLANTS SHOULD NOT BE USED IN AREAS WHERE THERE IS INADEQUATE COVERAGE OF HEALTHY, WELL VASCULARIZED TISSUE" AND :"SINCE 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 SURGEON REPORTED TO A POREX SURGICAL DISTRIBUTOR THAT THE PT RECEIVED A MEDPOR COMPLETE ORBIT-LEFT IMPLANT IN (B) (6) 2008. THE SURGEON REPORTED THAT THE PT RECEIVED RADIATION THERAPY PRIOR TO THE SURGERY. THE SURGEON STATED THAT THE PRIMARY SURGERY WAS A MAXILLO SINUS RESECTION OF THE CRANIAL ORBITAL AREA. THE SURGEON STATED THAT THE SURGERY WAS COMPLETED WITH NO EVIDENCE OF INFECTION PRESENT. THE SURGEON REPORTED THAT THE PT DEVELOPED AN INFECTION DAYS AFTER THE SURGERY. THE SURGEON STATED THAT THE INFECTION WAS TREATED WITH ANTIBIOTICS. THE SURGEON REPORTED THAT THE IMPLANT WAS REMOVED DAYS AFTER THE SURGERY. THE SURGEON STATED THAT THE PT'S CONDITION DETERIORATED AND THE INFECTION SPREAD TO THE BRAIN. THE SURGEON REPORTED THAT THE PT DIED AS A RESULT OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION LZK POREX SURGICAL NA D003D55H

    Patients

    Seq Age Sex Outcome Treatment
    1 Death