Description of Event or Problem · 1
WE DID A SERIES OF CERVICAL SURGERY CASES 2 YEARS AGO WITH A RESONABLE 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 (3 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 AND SCREWS. WE REPORTED THIS TO THE MFR AND KEPT A WATCHFUL EYE ON THIS. WE TRACKED THIS ONLINE AND WITH THE MFR AND FOUND NO SIMILAR CASES. THIS PT DID NOT REQUIRE RE-OPERATION BUT IS ONLY NOW STARTING TO FUSE MORE SOLIDLY. A SECOND CASE CAME THROUGH WITH A STABLE FUSION BUT A CYSTIC MASS AT THE SITE OF THE PLATE THAT HAD TO BE REMOVED DUE TO SWALLOWING DIFFICULTIES. WE ARE SEEING A THIRD CASE TOMORROW WITH EVIDENCE ON MRI OF BOTH INADEQUATE BONE GROWTH AND CYSTIC MASS AT THE SITE OF THE PLATE. WE DO NOT SEE COMPLICATIONS OF THIS NATURE IN ANY OF THE LARGE VOLUME OF CASES WE DO, USING OUR STANDARD TITANIUM PLATES/SCREWS. WE BELIEVE THAT WE ARE SEEING A HIGH RATE OF COMPLICATIONS IN THIS SMALL SAMPLE OF INION PTS AND WE BELIEVE THAT IT IS RELATED TO THE RESORBABLE MATERIAL. NOTE: ALL RELATED SCANS, REPORTS AND MD NOTES ARE IN THE RESPECTIVE PT CHARTS. DATES OF USE: (2005 - 2006).