Description of Event or Problem · 0
- DATE OF MEDICAL DEVICE USE: (B)(6) 2024. - REASON FOR USING THE MEDICAL DEVICE: PERFORMING ROOT CANAL TREATMENT FOR A PATIENT'S PULPITIS - STATUS OF MEDICAL DEVICE USAGE (WHETHER USED NORMALLY): USED NORMALLY - DATE OF ADVERSE EVENT OCCURRENCE: (B)(6) 2024. - SITUATION AT THE TIME OF MEDICAL DEVICE ADVERSE EVENT: THE PRODUCT FRACTURED AT THE APICAL THIRD, CAUSING AN OBSTRUCTION IN THE ROOT CANAL, LEADING TO THE FORMATION OF CHRONIC INFLAMMATION AT THE APEX, NECESSITATING LONG-TERM TREATMENT. - DATE OF ACTION TAKEN: (B)(6) 2024. - MEASURES TAKEN AFTER THE OCCURRENCE OF THE MEDICAL DEVICE ADVERSE EVENT: AFTER CONSULTATION WITH THE PATIENT, IT WAS DECIDED TO PROCEED WITH TOOTH EXTRACTION. - **DATE OF IMPROVEMENT OR OUTCOME OF THE ADVERSE EVENT**: (B)(6) 2024. - RESULT AFTER TREATMENT: THE PATIENT IS RECOVERING WELL.