BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANTS

    MDR report key: 2579996 · Received May 18, 2012

    Report

    Report Number
    1057129-2012-00003
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    May 30, 2012
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REPRESENTATIVE REPORTED THE FOLLOWING ITEM AND LOT NUMBERS:9510-F000179, EXPIRE DATE - 05.2020, MANUFACTURE DATE 05.2010.9509-F000788, EXPIRE DATE - 06.2020, MANUFACTURE DATE 06.2010.9525-F000791, EXPIRE DATE - 07.2020, MANUFACTURE DATE 07.2010.9526-F000792, EXPIRE DATE - 06.2020, MANUFACTURE DATE 06.2010.9429 (LOT NUMBER INFORMATION WAS NOT PROVIDED).9430 (LOT NUMBER INFORMATION WAS NOT PROVIDED).THE DEVICE HISTORY RECORDS FOR THE IMPLANTS LISTED WITH LOT NUMBER INFORMATION WAS REVIEWED AND ALL PROCESSES AND TEST CRITERIA WERE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    ITEM AND LOT NUMBER INFORMATION WAS NOT PROVIDED TO ENABLE AN INVESTIGATION.

    Description of Event or Problem · 1

    THE STRYKER SALES REPRESENTATIVE REPORTED THAT THE PATIENT HAD AN INFECTION WHILE USING MEDPOR PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other