BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1426027 · Received July 29, 2009

    Report

    Report Number
    1057129-2009-00007
    Event Type
    Injury
    Date Received
    July 29, 2009
    Report Date
    July 23, 2009
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT PROVIDE ITEM OR LOT # INFO. AFTER SEVERAL ATTEMPTS THE DOCTOR DID NOT PROVIDE ANY ADDITIONAL INFO CONCERNING THE REMOVAL.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO A DISTRIBUTOR THAT HE HAD SIX PTS THAT RECEIVED MEDPOR MANDIBLE IMPLANTS, AND EACH PT DEVELOPED AN INFECTION. THE DOCTOR REPORTED THAT HE REMOVED THE IMPLANTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other