NSK
Received Jul 29, 2026 · Event occurred Apr 13, 2026
Report 9611253-2026-00041 · MDR key 50065300
Device
Generic name
Handpiece, Air-powered, Dental
Manufacturer
Nakanishi Inc.Model number
Ti-Max X450 M4Catalog number
P1092
Product problems
- Gas/Air Leak
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
On (b)(6) 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 (b)(6) 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 dischargeFollow-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.