BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 823837 · Received February 28, 2007

    Report

    Report Number
    1057129-2007-00002
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    January 10, 2007
    Report Date
    February 20, 2007
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WERE CHECKED FROM PROCESSING TO FINISHED GOOD AND IS WITHIN SPEC. STERILITY TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. IN THE PAST 24 MOS, WE MFG 4620 PIECES AND DISTRIBUTED 3612 PIECES OF THE CHIN IMPLANTS. OF THE 3612 PIECES DISTRIBUTED, THE COMPLAINT PERCENTAGE RATE FOR THE PAST 24 MOS IS .0014. ENCLOSED IS A COPY OF THE INFO INSERT WITH CONTRAINDICATIONS AND CAUTIONS LISTED. THIS INSERT ACCOMPANIES EACH MEDPOR IMPLANT.

    Description of Event or Problem · 1

    THE DR STATED THAT HE PLACED A MEDPOR CHIN IMPLANT IN HIS PT TO ADD PROJECTION. THE DR REPORTED THAT HE PLACED THE IMPLANT INTRA ORALLY AND FIXED THE IMPLANT WITH TWO SCREWS ON EACH SIDE. TWO WEEKS AFTER SURGERY, THE AREA BECAME INFECTED. THE DR STATED THAT HE OPENED THE SITE TO CLEAN AND IRRIGATE THE AREA TO TRY TO RESOLVE THE INFECTION. THE DR STATED THAT HE REMOVED THE IMPLANT WHEN THE INFECTION DID NOT RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL, INC. NA 06002

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other