BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 678679 · Received February 22, 2006

    Report

    Report Number
    1057129-2006-00003
    Event Type
    Injury
    Date Received
    February 22, 2006
    Report Date
    February 13, 2006
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR REPORTED THAT HE PLACED A LEFT AND RIGHT MANDIBLE IMPLANT AND A CHIN IMPLANT ON HIS PT. THE DR STATED THAT THE RIGHT MANDIBLE IMPLANT SHIFTED ONE MONTH AFTER SURGERY FROM ITS ORIGINAL POSITION AND THE LEFT MANDIBLE IMPLANT SHIFTED EIGHT MONTHS AFTER SURGERY FROM ITS ORIGINAL POSITION. THE DR STATED THAT THE IMPLANTS SHIFTING LED TO AN INFECTION. THE DR STATED THAT HE DID NOT HAVE THE OPTION OF SCREWING THE POSTERIOR PART OF THE MANDIBLE IMPLANTS TO THE BONE BECAUSE OF UNDERLYING NERVES AND THERE WAS LITTLE BONE AVAILABLE FOR FIXATION. THE DR REPORTED THAT HE REMOVED THE LEFT MANDIBLE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL, INC. NA A021D52H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention