MANUFACTURER RECEIVED: (B)(4) 3 , SN (B)(4), DEVICE OBJECT OF THIS COMMUNICATION, AND RELATED HANDPIECES AND INSERTS ON MARCH 29, 2018 FOR INVESTIGATION PURPOSES. (B)(4) 3 MANUFACTURED ON 03/30/2014 WAS FOUND TO WORK APPROPRIATELY AS WELL AS THE HANDPIECE S.N. (B)(4). ALL FUNCTIONAL PARAMETERS RESULTED CORRECT WHILE THE HANDPIECE S.N. (B)(4) WAS BROKEN. THE INSERTS, THAT ARE THE COMPONENTS THAT COME INTO DIRECT CONTACT TO THE PATIENT, TO A CAREFUL ANALYSIS RESULTED ALL WORN AND BENDED IN DISAGREE WITH STATED BY THE MANUFACTURER AT SECTION 10.1 "IMPORTANT SAFETY INFORMATION REGARDING THE INSERTS" OF THE USER MANUAL. EVEN THE DIAMONDS INSERTS, WHICH, AS IS CLEARLY STATED IN THE USER MANUAL OF THE DEVICE, SECTION 06.6 INSERTS ARE SINGLE USE, HAVE WEAR LEVEL THAT SUGGESTS A REPEATED USE THAT IS NOT COMPATIBLE WITH THE STATEMENTS THE MANUFACTURER INCLUDED INTO THE IFU. MOREOVER THEIR PRODUCTION AND IN-PROCESS AND FINAL CONTROLS DOCUMENTS RELATED TO (B)(4) 3 AND RELATED INSERTS DID NOT SHOW ANY ANOMALY.
D
Patient 1
IT WAS REPORTED BY THE DISTRIBUTOR (B)(4) ON FEB. 27, 2018 THAT A DOCTOR HAD A PATIENT WHO RETURNED FOR A POST OPERATION CHECK UP ON (B)(6) 2018 AND WAS DISCOVERED TO HAVE SLOW POST-OPERATIVE HEALING AND NECROTIC BONE TISSUE ON THE LINGUAL RIDGE. PER THE DISTRIBUTOR (B)(4), ADDITIONAL TREATMENT WAS PERFORMED TO TREAT THE BONE NECROSIS ON (B)(6), (B)(6), AND (B)(6) TO REMOVE NECROTIC BONE ON THE LINGUAL RIDGE. THE ORIGINAL TREATMENT WAS FOR AN EXTRACTION. THE ORIGINAL TREATMENT DATE IS UNKNOWN; HOWEVER, IT WAS MENTIONED THAT THE ORIGINAL SURGERY OCCURED THREE (3) REPORTED MULTIPLE OTHER CASES OF THIS NATURE, BUT NO ADDITIONAL DETAILS WHERE PROVIDED REGARDING THOSE PATIENTS. ADDITIONAL MEDWATCH REPORTS WILL BE FILLED IF INFORMATION BECOMES AVAILABLE.