BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 2111725 · Received June 2, 2011

    Report

    Report Number
    1057129-2011-00013
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A PATIENT CAME IN WITH PAIN. THE DOCTOR STATED THAT HE DETECTED THAT A CHIN ABSCESS HAS BEEN BUILT. A REVISION SURGERY WAS NECESSARY. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT FWP STRYKER CRANIOMAXILLOFACIAL GEORGIA NA F003164

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other