{ "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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PATIENT HAS HAD TWO REVISIONS FROM A TOTAL TALUS TOA TOTAL TALUS WITH TOTAL ANKLE AND SUBTALAR FUSION. NOW, PHYSICIAN IS REVISING AGAIN WITH SPHERICAL-BOTTOM TALUS WITH TOTAL ANKLE AND STJ AND TN FUSION FOR BETTER SEATING AND FIXATION. THE DESIGN AND MANUFACTURING OF THE IMPLANTS MET ALL REQUIREMENTS AND SPECIFICATIONS. THE PHYSICIAN REPORTED DIFFICULTY SEATING THE IMPLANTS INTRAOPERATIVELY, WHICH HAS NOT BEEN ENCOUNTERED PRIOR IN RESTOR3D TOTAL TALUS CASES. ALL IMPLANTS PASSED DIMENSIONAL AND POLISHING INSPECTION, AND NO MANUFACTURING ERRORS WERE IDENTIFIED. THE SEATING DIFFICULTY MAY REFLECT UNEXPECTED INTRAOPERATIVE SOFT TISSUE OR ANATOMICAL CONSTRAINTS NOT FULLY CAPTURED DURING PREOPERATIVE PLANNING." }, { "mdr_text_key": "405691523", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PATIENT HAD A TALUS FRACTURE NONUNION WITH PREVIOUS TALAR REPLACEMENT WITH DEFORMITY AND ADVANCING ARTHROSIS. PATIENT HAS HAD TWO REVISIONS FROM A TOTAL TALUS TOA TOTAL TALUS WITH TOTAL ANKLE AND SUBTALAR FUSION. NOW, PHYSICIAN IS REVISING AGAIN WITH SPHERICAL-BOTTOM TALUS WITH TOTAL ANKLE AND STJ AND TN FUSION FOR BETTER SEATING AND FIXATION. THE DESIGN AND MANUFACTURING OF THE IMPLANTS MET ALL REQUIREMENTS AND SPECIFICATIONS. THE PHYSICIAN REPORTED DIFFICULTY SEATING THE IMPLANTS INTRAOPERATIVELY, WHICH HAS NOT BEEN ENCOUNTERED PRIOR IN RESTOR3D TOTAL TALUS CASES. ALL IMPLANTS PASSED DIMENSIONAL AND POLISHING INSPECTION, AND NO MANUFACTURING ERRORS WERE IDENTIFIED. THE SEATING DIFFICULTY MAY REFLECT UNEXPECTED INTRAOPERATIVE SOFT TISSUE OR ANATOMICAL CONSTRAINTS NOT FULLY CAPTURED DURING PREOPERATIVE PLANNING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "27709", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }