MAUDE Adverse Event Report: Nakanishi Inc. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number	Ti-Max X450 M4
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On july 8, 2026, nakanishi became aware of a malfunction of an nsk handpiece through a complaint input into the complaint database by a distributor (nsk america).According to the distributor, there are three handpieces suspected of being involved in the event, but the dental office could not determine which of three handpieces was used during the following event.Therefore, nakanishi is submitting three separate mdrs for this event.This mdr is regarding the handpiece with the serial number (b)(6).Details are as follows: the event occurred on april 13, 2026.The dentist was performing a dental procedure on a patient using the ti-max x450 m4 handpiece (serial no.(b)(6)).During the procedure, the patient experienced postoperative swelling consistent with air entering the tissue.The swelling experienced by the patient resolved with ice before discharge.Follow-up confirmed there were no lasting complications or need for additional medical treatment.
Additional Manufacturer Narrative
The dental office declined to provide information about the patient.

• Brand Name: NSK
• Common Device Name: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): Nakanishi Inc.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): Nakanishi Inc.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; +1(224)512-8921
• MDR Report Key: 50065259
• Report Number: 9611253-2026-00040
• Device Sequence Number: 18661519
• Product Code: EFB
• UDI-Device Identifier: 04560264572645
• UDI-Public: (01)04560264572645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: Ti-Max X450 M4
• Device Catalogue Number: P1092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown