BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR MANDIBULAR ANGLE RZ RIGHT - LARGE

    MDR report key: 2162020 · Received July 14, 2011

    Report

    Report Number
    1057129-2011-00026
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION. THE PURCHASING AGENT INDICATED THAT THE IMPLANT WAS NOT THE REASON FOR IMPLANT REMOVAL.

    Description of Event or Problem · 1

    A REPRESENTATIVE FROM THE DOCTOR'S OFFICE STATED THAT THE PATIENT RECEIVED A MEDPOR MANDIBULAR ANGLE RZ RIGHT IMPLANT. THE REPRESENTATIVE STATED THAT THE IMPLANT "BOTHERED" THE PATIENT AND WAS REMOVED. THE REPRESENTATIVE STATED THAT THE IMPLANT WAS SENT TO A LAB FOR TESTING AND THE RESULTS WERE NEGATIVE FOR INFECTION DURING NUMEROUS CULTURES. THE REPRESENTATIVE STATED THAT THE IMPLANT WAS INTACT AFTER REMOVAL. THE REPRESENTATIVE STATED THAT THE IMPLANT WAS NOT THE REASON FOR REMOVAL. THE REPRESENTATIVE REPORTED THAT THE PATIENT IS IN EXCELLENT CONDITION AFTER THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR MANDIBULAR ANGLE RZ RIGHT - LARGE IMPLANT FWP STRYKER CRANIOMAXILLOFACIAL GEORGIA NA F051D05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other