BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS BABY BIODEGRADABLE FIXATION SYSTEM

    MDR report key: 2230822 · Received August 22, 2011

    Report

    Report Number
    9710629-2011-00008
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    February 3, 2010
    Report Date
    August 19, 2011
    Manufacturer
    INION OY
    Product Code
    JEY
    PMA / PMN Number
    K010351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - INSPECTION OF DEVICE HISTORY RECORD. SIMILAR REACTIONS TO HYDROSET HAVE BEEN PREVIOUSLY REPORTED TO THE FDA (I.E., POSTOPERATIVE INFECTION, CSF LEAK, HEMATOMA, ADVERSE TISSUE REACTION, SWELLING, DISCOMFORT AND PAIN. PLEASE NOTE THAT ALTHOUGH TISSUE REACTIONS ARE POSSIBLE AFTER IMPLANTATION OF ANY FOREIGN MATERIAL TO THE BODY, THE TISSUE REACTIONS SOMETIMES SEEN AFTER IMPLANTATION OF BIODEGRADEABLE POLYMER IMPLANTS (SUCH AS THE INION CPS BABY IMPLANTS) TYPICALLY OCCUR FIRST WHEN THE MATERIAL DEGRADES. THE INION CPS BABY IMPLANTS DEGRADE IN 1-3 YEARS. IT IS THEREFORE VERY UNLIKELY THAT THE DESCRIBED COMPLICATIONS WOULD HAVE BEEN CAUSED BY THE INION CPS BABY PRODUCTS. IN CONCLUSION, THE EVENT WAS NOT CAUSED BY INION DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFORMATION, INION CPS BABY PLATE AND SCREWS WERE USED TOGETHER WITH STRYKER HYDROSET BONE SUBSTITUTE IN SINUS INFECTION SURGERY. APPROXIMATELY 2-3 MONTHS POSTOPERATIVELY, THE PATIENT EXPERIENCED HEAD PAIN. SCANS WERE COMPLETED AND THE SURGEON DECIDED TO REMOVE HYDROSET - STATED THAT PATIENT WAS HAVING A REACTION TO THE HYDROSET. PATIENT STATED THAT BONE IS SEEMING TO BE GROWING THICKER IN THE REGION WHERE THE HYDROSET WAS. ALSO CSF LEAK. ACCORDING TO THE PATIENT THE SURGEON ENCOUNTERED HYDROSET AROUND THE PLATE, REMOVED IT AND IMMEDIATELY ENCOUNTERED A VERY THICK INTENSE GRANULATION TISSUE, WHICH CONTINUES TO BE FOUND. PATIENT CONTINUED TO HAVE COMPLICATIONS WITH THE SURGICAL AREA AND HAD THE AREA SCRAPED CLEAN 2 MORE TIMES. PATIENT IS STILL HAVING PROBLEMS. HAD OTHER DOCTORS AT A DIFFERENT FACILITY REVIEW HER PROCEDURES AND PERFORM ADDITIONAL SCRAPINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BABY BIODEGRADABLE FIXATION SYSTEM BONE PLATE JEY INION OY PLT-1001 0705008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INION CPS BABY SCREWS FOR PLATE FIXATION, (B)(4)