BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1050177 · Received May 23, 2008

    Report

    Report Number
    1057129-2008-00015
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 15, 2008
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 8313-C008B13H, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION. ENCLOSED IS A COPY OF THE CURRENT MEDPOR INSTRUCTIONS FOR USE WITH CONTRAINDICATION HIGHLIGHTED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE PATIENT RECEIVED A MEDPOR CHIN IMPLANT IN 2007. THE DOCTOR STATED THAT THE IMPLANT WAS PLACED INTRA ORALLY AND WAS NOT COVERED DURING INSERTION. THE DOCTOR STATED THAT THREE MONTHS POST OP, THE PATIENT "HAD SOME TROUBLE WITH THE WOUND" AND PRESENTED WITH A FISTULA ON THE RIGHT MANDIBLE BODY JUST BEYOND THE LATERAL END OF THE MEDPOR CHIN IMPLANT. THE DOCTOR STATED THAT THE FISTULA WAS CUT OUT ALLOWING IT TO GRANULATE IN. THE DOCTOR STATED THAT AN INFECTION WAS NOTICED IN APPROX EIGHT MONTHS LATER. THE DOCTOR STATED THAT THE INFECTION WAS TREATED WITH ANTIBIOTICS. THE DOCTOR REPORTED THAT THE FISTULA RETURNED AND THE IMPLANT WAS REMOVED IN 2008. THE DOCTOR STATED THAT THE PATIENT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION LZK POREX SURGICAL NA C008B13H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other