BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1631294 · Received March 12, 2010

    Report

    Report Number
    1057129-2010-00006
    Event Type
    Injury
    Date Received
    March 12, 2010
    Date of Event
    December 29, 2009
    Report Date
    March 10, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO A POREX SALES REPRESENTATIVE THAT THE PATIENT RECEIVED TWO MEDPOR RZ MANDIBLE ANGLES IN (B) (6) 2009. THE DOCTOR STATED THAT AN INFECTION DEVELOPED IN THE AREA SURROUNDING ONE OF THE MANDIBLE IMPLANTS. THE DOCTOR STATED THAT HE TREATED AN INFECTION WITH ANTIBIOTICS (CLINDAMYCIN) SEVERAL TIMES. THE DOCTOR REPORTED THAT THE PATIENT IS DOING BETTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other