BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPANT

    MDR report key: 1961638 · Received January 14, 2011

    Report

    Report Number
    1057129-2011-00002
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    February 11, 2011
    Manufacturer
    POREX SURGICAL
    Product Code
    FWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER INFORMATION WAS NOT PROVIDED; THEREFORE AN INVESTIGATION OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO THE DISTRIBUTOR THAT THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 1

    THE DOCTOR STATED TO THE DISTRIBUTOR THAT THE PATIENT RECEIVED A MEDPOR TWO PIECE DESIGN CHIN IMPLANT IN (B)(6) OF 2009. THE DOCTOR STATED THAT THE PATIENT PRESENTED FREQUENT INFLAMMATORY PROCESS WITH EDEMA IN THE ENTIRE CHIN AREA. THE DOCTOR STATED THAT THE USE OF ANTI-INFLAMMATORY AND ANTIBIOTIC MEDICATION WOULD IMPROVE THE AREA. THE DOCTOR STATED THAT APPROXIMATELY FOUR MONTHS AGO, THE PATIENT PRESENTED WITH DRAINAGE OF SECRETION BY A POINT OF THE SKIN IN THE INFERIOR REGION OF THE CHIN. THE DOCTOR STATED THAT AT THAT TIME, THE SECRETION WAS SENT OUT FOR ANALYSIS. THE DOCTOR STATED THAT THE CULTURE WAS GRAM NEGATIVE AND FUNGI. THE DOCTOR STATED THAT AT THE TIME IT WAS NOTICED THAT THE IMPLANT WAS INTEGRATED INTO THE BONE AND WITH THE INFLAMMATORY PROCESS IN MOBILE PARTS. THE DOCTOR STATED THAT PATIENT RETURNED AFTER ONE MONTH WITH THE SAME DRAINAGE AND SECRETION THROUGH THE LEFT INFERIOR REGION OF THE CHIN. THE DOCTOR STATED THAT THREE NEW DEBRIDGEMENTS WERE MADE BUT THE INFLAMMATORY PROCESS REMAINED. THE DOCTOR STATED THAT THE PATIENT IS CURRENTLY USING ANTIBIOTIC AND ANTI-FUNGI. THE DOCTOR STATED THAT THEY ARE AWAITING NEW CULTURE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPANT MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANFACIAL SHAPES FWP POREX SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O