BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT

    MDR report key: 2402119 · Received January 6, 2012

    Report

    Report Number
    1057129-2012-00001
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    August 19, 2011
    Report Date
    January 12, 2012
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR STATED THAT BOTH IMPLANTS WERE EXPLANTED. THE DISTRIBUTOR REPORTED THAT THE PATIENT DID NOT COME BACK FOR A FOLLOW UP AND THE STATUS OF THE PATIENT IS NOT KNOWN. THE ADDITIONAL IMPLANT INFORMATION IS AS FOLLOWS: ITEM NUMBER: 9525; LOT NUMBER: C106H11; EXPIRATION DATE: 08-2017; MANUFACTURE DATE: 08-2007. THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO THE DISTRIBUTOR THAT THE PATIENT RECEIVED LEFT AND RIGHT MEDPOR PARANASAL IMPLANTS ON (B)(6) 2011. THE DOCTOR REPORTED THAT AN INFECTION OCCURRED ONE AND ONE HALF MONTH AFTER THE OPERATION. THE DOCTOR REPORTED THAT HE EXPLANTED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT IMPLANT FWP STRYKER CRANIOMAXILLOFACIAL GEORGIA NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other