{ "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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(B)(4)." }, { "mdr_text_key": "187140853", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ACCORDING TO RESULTS OF THE INVESTIGATION, THE CAUSE IDENTIFIED IS A USER FAILURE TO FOLLOW IFU. IT WAS NOTED THAT THE SKIN OF THE PATIENT FACE WAS SWOLLEN DUE THE POSITION OF THE HEAD FRAME PINS AND WAS SCANNED BY THE USER. IT IS NOTED IN THE IFU THAT THE SCANNED ZONES SHOULD BE FREE OF ANY REFLECTIVE PRODUCT OR ANY PRODUCT THAT COULD STRETCH THE SKIN. THE ROSA DEVICE FUNCTIONED AS INTENDED." }, { "mdr_text_key": "187141211", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN ADVERSE EVENT OR PRODUCT PROBLEM', THE 'DATE OF EVENT' IS CORRECTED: THE CORRECT EVENT DATE IS (B)(6) 2017." }, { "mdr_text_key": "78382108", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "78382109", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING THE SURGERY, THE REGISTRATION STEP HAD TO BE REPEATED THREE TIMES. DURING THE SECOND ATTEMPT IT WAS NOTICED A PATIENT SKIN SWELLING AROUND THE FOREHEAD FROM THE CRW STEREOTACTIC FRAME PINS, AND THE PATIENT CHEEKS WERE PRESSED UP AGAINST THE NOSE. THE 3RD REGISTRATION WAS PERFORMED AVOIDING THE CRW STEREOTACTIC FRAME PINS AND WAS SUCCESSFUL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/05/2017;12/14/2017;12/20/2017" } ] }