BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 829979 · Received March 16, 2007

    Report

    Report Number
    1057129-2007-00004
    Event Type
    Injury
    Date Received
    March 16, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 5, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR INDICATED THAT THE IMPLANT WAS IN GOOD CONDITION AFTER IT WAS EXPLANTED. THE DEVICE HISTORY RECORDS FOR THIS LOT WERE CHECKED FROM PROCESSING TO FINISHED GOOD AND IS WITHIN SPECIFICATION. STERILITY TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. IN THE PAST 24 MONTHS, WE MANUFACTURED 772 PIECES AND DISTRIBUTED 691 PIECES OF THE NASAL IMPLANTS AND OF THE 691 PIECES DISTRIBUTED, THE COMPLAINT PERCENTAGE RATE FOR THE PAST 24 MONTHS IS .0072. ENCLOSED IS A JOURNAL ARTICLE ENTITLED "NASAL RECONSTRUCTION USING POROUS POLYETHYLENE IMPLANTS".

    Description of Event or Problem · 1

    THE DOCTOR STATED, THAT HE PLACED A MEDPOR NASAL IMPLANT IN 2005. THE DOCTOR STATED, THAT THE PT HAD AN EXPOSURE ON THE INSIDE NOSTRIL AT THE BOTTOM EDGE OF THE IMPLANT. THE DOCTOR REMOVED THE IMPLANT IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL NA 7167

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other