BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CUSTOMIZED MIDFACE

    MDR report key: 4208919 · Received October 29, 2014

    Report

    Report Number
    0008010177-2014-00297
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    FWP
    PMA / PMN Number
    K121315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE DEVICES WERE NOT RETURNED FOR INVESTIGATION, THE REPORTED EVENT COULD BE CONFIRMED BASED ON THE PROVIDED BACTERIOGICAL REPORT. ON INQUIRY STRYKER RECEIVED THE REPORT OF THE BACTERIOLOGY FROM THE RELATED UNIVERSITY HOSPITAL, WHICH WAS REVIEWED AND EVALUATED BY STRYKER CMF¿S CLINICAL EXPERT. THE REPORT SHOWS THAT ALL OF THE ANALYZED GERMS ORIGINATED FROM THE ORAL CAVITY. THE CLINICAL EXPERT REASONED THAT THE PATIENT¿S GERMS CAUSED THE INFECTION PRIMARILY. MOST LIKELY THE ABSCESS GERMS WERE INTRAOPERATIVELY INTRODUCED FROM THE ORAL CAVITY. SUMMARIZING THE INVESTIGATION THE ROOT CAUSE OF THE DETERMINED FAILURE MODE CAN BE TIED TO A PATIENT / USER RELATED ISSUE. INDICATIONS FOR ANY MATERIAL OR DESIGN RELATED ISSUES WERE NOT DETERMINED IN THE INVESTIGATION. THEREFORE, NO PREVENTIVE/CORRECTIVE ACTION IS REQUIRED AT THIS TIME. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE DEVICE IS SENT BACK, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE STILL IMPLANTED.

    Description of Event or Problem · 1

    DURING A COMPANY REPRESENTATIVES VISIT AT THE (B)(6), IT WAS MENTIONED THAT POSTOPERATIVELY AN INFECTION OCCURRED, AFFECTING A PATIENT WHO RECEIVED TWO MEDPOR CUSTOMIZED MIDFACE IMPLANTS WHICH WERE IMPLANTED ON (B)(6) 2014. THE INFECTION DEVELOPED AT ONE OF THE TWO SIDES. AS OF (B)(6) 2014 THE DEVICES WERE STILL IN SITU. THE DECISION TO REMOVE ONE OR BOTH IMPLANTS AND DETERMINE IF FURTHER TREATMENT IS REQUIRED IS PENDING.

    Description of Event or Problem · 1

    DURING A COMPANY REPRESENTATIVES VISIT AT THE (B)(4), IT WAS MENTIONED THAT POSTOPERATIVELY AN INFECTION OCCURRED, AFFECTING A PATIENT WHO RECEIVED TWO MEDPOR CUSTOMIZED MIDFACE IMPLANTS WHICH WERE IMPLANTED ON (B)(6) 2014. THE INFECTION DEVELOPED AT ONE OF THE TWO SIDES. AS OF (B)(6) 2014 THE DEVICES WERE STILL IN SITU. THE DECISION TO REMOVE ONE OR BOTH IMPLANTS AND DETERMINE IF FURTHER TREATMENT IS REQUIRED IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692190 MEDPOR CUSTOMIZED MIDFACE IMPLANT FWP STRYKER LEIBINGER FREIBURG K09428LF26MAY LEFT

    Patients

    Seq Age Sex Outcome Treatment
    1