{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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KEY TOPICS INCLUDED CT SIMULATION AND FIDUCIAL PLACEMENT, TREATMENT PLANNING STRATEGIES (WITH EMPHASIS ON DOSE DISTRIBUTION AND MARGIN SELECTION), AND DELIVERY QUALITY, INCLUDING MANAGING UNCERTAINTIES AND DEVIATIONS. THE TEAM COMPARED CURRENT PRACTICES WITH LITERATURE-BACKED RECOMMENDATIONS TO IMPROVE OUTCOMES. THE CUSTOMER WAS PROVIDED WITH A DETAILED REVIEW OF (B)(4) PATIENTS TREATED BETWEEN 2020 AND 2024, HIGHLIGHTING TOXICITY OUTCOMES, PLANNING TECHNIQUES, AND DELIVERY METRICS LIKE RIGID BODY ERROR AND SPACING. BEST PRACTICES WERE REINFORCED ACROSS ALL STAGES¿FROM FIDUCIAL PLACEMENT TO PATIENT SETUP AND TREATMENT DELIVERY¿TO ALIGN CLINICAL RESULTS WITH PUBLISHED CYBERKNIFE ADVANTAGES." }, { "mdr_text_key": "376405116", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A CUSTOMER IN ITALY HAS OBSERVED RECTAL TOXICITIES. THIS IS A KNOWN SIDE EFFECT OF RADIATION TREATMENT FOR PROSTATE CANCER. ACCORDING TO THE SITE, THIS PATIENT RECEIVED GRADE 3 RECTAL TOXICITY. A CLINICAL ASSESSMENT WAS PERFORMED WITHIN ACCURACY AND IT WAS DETERMINED THAT THE TOXICITY WAS GRADE 2. THE GRADE 2 TOXICITY WAS DETERMINED TO BE A SERIOUS INJURY. THERE IS NO INDICATION THAT THE SYSTEM MALFUNCTIONED. THIS EVENT IS STILL UNDER INVESTIGATION." }, { "mdr_text_key": "376405117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "RECTAL TOXICITY DUE TO PROSTATE TREATMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1209 DEMING WAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "53717", "manufacturer_contact_exchange": "608", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/14/2025" } ] }