MAUDE Adverse Event Report: MECTRON S.P.A. PIEZOSURGERY; OT7S-4, INSERT TO PIEZOSURGERY

Model Number	OTS7-4
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The risk of insert tip breakage has already been identified and is clearly mentioned within our instruction of use for piezosurgery inserts and within our risk analysis.This kind of breakage could be cause by several factors.Nevertheless, we did not receive enough information to provide a final conclusion.The dentist must refer to recommendations included in the user manual, about the safety requirements during use, where it is recommended to check in case of breakage of the insert tip that no fragments remain in the treated part and to efficiently aspirate and remove such parts.The broken insert tip was not returned to the manufacturer for investigation and the information provided was not sufficient.Despite several reminders to the doctor, our distributor did not succeed in convincing the dentist to remove the fragment from the bone and provide information about the current health status of the patient.Device not returned by doctor.
Event or Problem Description
Doctor was performing an alveolar ridge split.Doctor broke the insert tip in patient bone.Doctor placed dental implant.Doctor took dental x-rays and observed broken insert tip in bon in x-ray.Doctor removed implant and attempted to retrieve broken insert tip.Doctor was unable to retrieve insert tip.Doctor replaced dental implant.Doctor contacted piezosurgery incorporated for advice on how to proceed.Doctor was advised to remove the broken insert tip.Doctor stated that because the insert tip is composed of similar material to that of surgical steel and titanium in wires and other dental hardware that is made to remain in the body, that he would leave the insert tip in the bone of the patient and monitor the patient.Piezosurgery incorporated indicated that the device manual explicitly states to remove insert fragments.Doctor stated that to remove the tip insert, he would have to abort his procedure.Piezosurgery incorporated advised the doctor to abort the procedure.Piezosurgery incorporated stated that it would report the event and sent the doctor rma paperwork and adverse event forms to fill out.Doctor failed to return email, phone calls, and certified mail correspondence, as well as any patient information or associated paperwork.Therefore, no patient information has been listed in this form.The piezosurgery 3 device was used with the ot7s-4 insert tip (insert tip was purchased in 2011).

• Brand Name: PIEZOSURGERY
• Common Device Name: OT7S-4, INSERT TO PIEZOSURGERY
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a, 16042 carasco; genova, ; IT
• MDR Report Key: 6330142
• Report Number: 3003933619-2017-00001
• Device Sequence Number: 10907534
• Product Code: DZI
• UDI-Device Identifier: E322033700140
• UDI-Public: E322033700140
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/23/2017
• Report Date (Section F): 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Model Number: OTS7-4
• Device Catalogue Number: 03370014
• Device Lot Number: 11/00153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2016
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 39 YR
• Date Report Sent to FDA: 01/23/2017