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20111 registryClear
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Not graded by the source2011-04-15FDA MAUDE2950679-2011-00002CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PT TREATED FOR A MID-PARENCHYMAL LEFT LOWER LOBE MASS EXPERIENCED A COLLAPSE OF THE LEFT LOWER LOBE EIGHT MONTHS AFTER TREATMENT. THIS EVENT IS CONSIDERED A KNOWN RISK OF TREATING SUCH A TUMOR IN THIS LOCATION AND IS NOT ATTRIBUTED TO MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PT HAS DEMONSTRATED FAVORABLE RESPONSE TO TREATMENT WITH MARKED REGRESSION IN TUMOR SIZE AND IMPROVED CONTROL OF DISEASE.
cause not established2950679-2011-00002AccurayRead the record ↗