BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1216641 · Received October 28, 2008

    Report

    Report Number
    1057129-2008-00025
    Event Type
    Injury
    Date Received
    October 28, 2008
    Report Date
    October 17, 2008
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PATIENT RECEIVED A MEDPOR MANDIBULAR ANGLE/INFERIOR BORDER IMPLANT APPROXIMATELY 18 MONTHS AGO WITHOUT COMPLICATIONS. THE DOCTOR STATED THAT RECENTLY THE PATIENT DEVELOPED A FACIAL INFECTION IN THE AREA WHERE THE IMPLANT IS LOCATED. THE DOCTOR STATED HE COULD NOT DETERMINE A CAUSE OF THE INFECTION. THE DOCTOR STATED THAT THE PATIENT REQUESTED REMOVAL OF THE IMPLANT. THE DOCTOR REQUESTED INFORMATION ON THE REMOVAL OF MEDPOR IMPLANTS. THE DOCTOR CONTACTED A SURGEON WHO HAS MANY YEARS OF EXPERIENCES WITH MEDPOR IMPLANT PLACEMENT AND REMOVAL. THE DOCTOR REMOVED THE IMPLANT AND STATED THAT THE INFECTION SEEMED TO MANIFEST AT THE ANTERIOR EXTENSION OF THE IMPLANT NEAR THE OSTEOTOMY WHERE THERE WAS PRESENCE OF A GELATINOUS MASS BUT IT COULD NOT BE DETERMINED WHAT CAUSED THE INFECTION AND HE COULD NOT ISOLATE IT TO THE IMPLANT BECAUSE OF THE LOCATION. THE DOCTOR STATED THAT THE PATIENT IS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other