BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1667033 · Received April 21, 2010

    Report

    Report Number
    1057129-2010-00010
    Event Type
    Injury
    Date Received
    April 21, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 20, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 89020-MCI-096-10 F012C28H, 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 REPORTED TO THE POREX SURGICAL SALES REPRESENTATIVE THAT THE PT RECEIVED A MEDPOR RIGHT CRANIAL IMPLANT ON (B) (6), 2010. THE DOCTOR STATED THAT THE PT WAS HAVING AN ACUTE INFLAMMATORY REACTION AND THE MEDPOR RIGHT CRANIAL IMPLANT WAS EXPLANTED ON (B) (6), 2010. THE DOCTOR STATED THAT IT WAS A (B) (6) INFECTION THAT CAUSED THE PT TO DEGRADE RAPIDLY WITHIN 36 HOURS AFTER IMPLANTATION. THE DOCTOR REPORTED THAT THE PT IS ON ANTIBIOTICS AND DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION LZK POREX SURGICAL NA MCI-09610 F012C28H

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other