BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1649940 · Received March 31, 2010

    Report

    Report Number
    1057129-2010-00007
    Event Type
    Injury
    Date Received
    March 31, 2010
    Report Date
    March 29, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY FOR 89020-MCI-285-06-B004M131H WAS REVIEWED AND ALL TEST CRITERIA AND PROCESSES WERE WITHIN SPECIFICATION FOR THE MEDPOR IMPLANT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE PATIENT RECEIVED A MEDPOR CUSTOM CRANIAL IMPLANT IN 2006 PLACED BY ANOTHER SURGEON. THE DOCTOR STATED THAT PUS WAS ON BOTH SIDES OF THE AREA AROUND THE IMPLANT. THE DOCTOR STATED THAT HE DRAINED AND TREATED THE AREA WITH ANTIBIOTICS. THE DOCTOR STATED THAT THE AREA IS "CLEARING UP NICELY." THE DOCTOR STATED THAT THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION LZK POREX SURGICAL NA MCI28506 B004M131H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other