MAUDE Adverse Event Report: MECTRON S.P.A PIEZOSURGERY; PIEZOELECTRIC INSERT TIP

Model Number 3400002

Device Problem Insufficient Information (3190)

Patient Problem Necrosis (1971)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Piezosurgery inc.Was informed by the doctor on 11/05/2019 of an event that occured in 2015 (exact date unknown).It was reported that the patient experienced bone loss after an extraction surgery using a piezosurgery touch device and ex1 insert tip which the doctor attributed to necrosis.Necrotic bone was removed and a secondary extraction of a nearby tooth was performed to prevent further patient complications.The restoration was completed without further complications.

Event Description

Piezosurgery inc.Was informed by the doctor on (b)(6) 2019 of an event that occured in 2015 (exact date unknown).It was reported that a piezosurgery touch device and an ex2 insert tip were used for an extraction procedure intended to remove tooth 11.At 6 weeks post-op bone necrosis was detected at mesial 12 and at 12 weeks post-op bone loss extended to distal 12.At 19 weeks post-op the tooth (12) was removed.Necrotic bone was removed, bone grafting material was added, and an additional implant was placed.The restoration was completed without further complications.

• Brand Name: PIEZOSURGERY
• Type of Device: PIEZOELECTRIC INSERT TIP
• Manufacturer (Section D): MECTRON S.P.A; mectron s.p.a; via loreto 15a; carasco, 16042 ; IT 16042
• MDR Report Key: 9397276
• MDR Text Key: 168798880
• Report Number: 3005282635-2019-00001
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/23/2019,11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3400002
• Device Catalogue Number: 03400002
• Device Lot Number: CK/07044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Distributor Facility Aware Date: 11/05/2019
• Event Location: Other
• Date Report to Manufacturer: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PIEZOSURGERY TOUCH DEVICE AND HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR