BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR IMPLANT

    MDR report key: 832517 · Received March 26, 2007

    Report

    Report Number
    1057129-2007-00006
    Event Type
    Other
    Date Received
    March 26, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WERE CHECKED FROM PROCESSING TO FINISHED GOOD AND ARE WITHIN SPECIFICATION. STERILITY TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. ENCLOSED IS A COPY OF THE INFORMATION INSERT WITH CONTRAINDICATIONS AND CAUTIONS LISTED. THIS INSERT ACCOMPANIES EACH MEDPOR IMPLANT.

    Description of Event or Problem · 1

    THE ASSISTANT FOR THE OMF SURGEON REPORTED THAT A PATIENT RECEIVED BI-LATERAL MALAR IMPLANTS INTRA ORALLY IN JUNE 2005. THE AREA WHERE THE LEFT MALAR IMPLANT WAS PLACED BECAME INFECTED FOUR WEEKS POST OP. THE DOCTOR TREATED THE AREA WITH ANTIBIOTICS, BUT WHEN THE INFECTION DID NOT RESOLVE, THE DOCTOR REMOVED THE IMPLANT. THE PHYSICIAN'S ASSISTANT REPORTED THAT THE INFECTION CLEARED SINCE THE IMPLANT WAS REMOVED AND THE PATIENT IS DOING WELL. THE DOCTOR IS PREPARING TO PLACE ANOTHER LEFT MALAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL NA 7537

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other