BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR IMPLANT

    MDR report key: 967348 · Received December 18, 2007

    Report

    Report Number
    1057129-2007-00023
    Event Type
    Other
    Date Received
    December 18, 2007
    Report Date
    December 17, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    HPZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA HAVE BEEN VERIFIED AS COMPLYING WITH THE MEDPOR IMPLANT SPECIFICATION. A COPY OF THE CURRENT INSTRUCTIONS FOR USE AND LABELING WITH CAUTIONS HIGHLIGHTED IS ENCLOSED ADDL. LOT NUMBER C012K117H.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT A PATIENT RECEIVED A MEDPOR LEFT ORBITAL RIM/ZYGOMATIC ONLAY IMPLANT IN 2007. THE DOCTOR STATED THAT WHILE THE IMPLANT FIT GREAT, THE IMPLANT AREA BECAME INFECTED WITHIN 3 TO 4 FOUR DAYS AFTER THE SURGERY AND HE REMOVED IT. THE DOCTOR STATED THAT HE HAS NEVER HAD A PROBLEM WITH AN ORBITAL IMPLANT AND WILL REACCESS HOW HE PLACES IMPLANTS INTRAORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION HPZ POREX SURGICAL NA MCI28607

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other