MAUDE Adverse Event Report: MECTRON S.P.A PIEZOSURGERY; PIEZOSURGERY 3

Model Number 5120035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Impaired Healing (2378)

Event Date 02/06/2018

Event Type  Injury  

Event Description

It was first reported by the sales representative 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 sales rep, additional treatment was performed to treat the bone necrosis on (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 provided that the original surgery occurred three (3) months prior to the intervention date.The patient status at this time is unknown.The doctor also reported multiple other cases of this nature, however no additional details were provided regarding those patients.Additional medwatch reports will be filed if the information becomes available.

• Brand Name: PIEZOSURGERY
• Type of Device: PIEZOSURGERY 3
• Manufacturer (Section D): MECTRON S.P.A; via loreto 15a; carasco, ge 16042 ; IT 16042
• MDR Report Key: 7490923
• MDR Text Key: 107497471
• Report Number: 3005282635-2018-00001
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/23/2018,02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 5120035
• Device Catalogue Number: 5120035E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2018
• Distributor Facility Aware Date: 02/27/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; (B)(4) ; HANDPIECE (B)(4) ; HANDPIECE (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR