BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION AMERICA

    MDR report key: 1296304 · Received January 26, 2009

    Report

    Report Number
    MW5009749
    Event Type
    Injury
    Date Received
    January 26, 2009
    Report Date
    January 21, 2009
    Manufacturer
    FINNISH COMPANY ( INION)
    Product Code
    OJB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE DID A SERIES OF CERVICAL SURGERY CASES 2 YEARS AGO WITH A RESORBABLE PLATE AND SCREWS CALLED "INION". WE ARE NOW SEEING A THIRD CASE OF WHAT APPEARS TO BE LONG TERM AND UNUSUAL REACTIONS TO THIS RESORBABLE PRODUCT. (THREE PTS SO FAR). WE DID A SMALL SERIES OF CASES USING RESORBABLE PLATES AND SCREWS ABOUT 2 YEARS AGO. ABOUT 8 MONTHS AFTER THIS, WE SAW A PT BACK WHO APPEARED TO HAVE SOME RESORBTION OF BONE RELATED TO THE PLATE SCREWS. WE REPORTED THIS TO THE MANUFACTURER AND KEPT A WATCHFUL EYE ON THIS. WE TRACKED THIS ONLINE AND WITH THE MANUFACTURER AND FOUND NO SIMILAR CASES. THIS PT DID NOT REQUIRE RE-OPERATION, BUT IS ONLY NOW STARTING TO FUSE MORE SOLIDLY. DATE OF USE: 2005 - 2006. NOTE: ALL RELATED SCANS, REPORTS AND MD NOTES ARE IN THE RESPECTIVE PT CHARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION AMERICA CERVICAL PLATE AND SCREWS OJB FINNISH COMPANY ( INION)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O