BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1401431 · Received June 10, 2009

    Report

    Report Number
    1057129-2009-00004
    Event Type
    Injury
    Date Received
    June 10, 2009
    Report Date
    June 9, 2009
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 89020-MCI-400-08H, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PATIENT RECEIVED A MEDPOR FRONTAL CRANIAL IMPLANT IN 2008. THE DOCTOR STATED THAT THE IMPLANT WAS WELL CONSTRUCTED AND THE RESULTS WERE GOOD AFTER THE SURGERY. THE DOCTOR REPORTED IN 2009 THAT THERE WAS A BREAKDOWN OF TISSUE IN THE AREA OF THE IMPLANT AND HE NEEDED TO REPLACE THE IMPLANT. THE DOCTOR REQUESTED A MODIFIED DESIGN OF THE FRONTAL CRANIAL IMPLANT AND WHILE AWAITING THE NEW IMPLANT, THE PATIENT DEVELOPED AN INFECTION IN THE AREA AND THE DOCTOR REMOVED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL NA MCI400-08D018M131H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other