MAUDE Adverse Event Report: NAKANISHI INC. NSK; DENTAL HANDPIECE

Model Number	X450 5H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was adjusting a crown when there was a popping noise, and the head came off the body of the device into the patient's mouth breaking the internal glass rod.Small metal parts were observed in the patients mouth as well as pieces from the glass rod.Suction was used to remove the particles.Patient did not sustain any injury and there was no need for medical treatment.A follow up was conducted with the patient and there were no complications from the event reported.

• Brand Name: NSK
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 11179757
• Report Number: 1422375-2021-00003
• Device Sequence Number: 2385137
• Product Code: EFB
• UDI-Device Identifier: 04560264532472
• UDI-Public: 04560264532472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/15/2021
• Report Date (Section F): 01/15/2021

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: Health Professional
• Device Model Number: X450 5H
• Device Catalogue Number: P1093001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2021
• 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
• Date Report Sent to FDA: 01/15/2021