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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX Z; DENTAL HANDPIECE
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NAKANISHI INC. TI-MAX Z; DENTAL HANDPIECE Back to Search Results
Model Number Z890L
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/30/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor was performing a crown preparation when he noticed that the handpiece began to lose power and was not cutting well, it then became noticeably louder and the bur along with the internal parts just shot out into the patient's mouth.The doctor was able to quickly retrieve the parts and the patient was not affected.
 
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Brand Name
TI-MAX Z
Common Device Name
DENTAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA  322-8666
MDR Report Key19580550
Report Number1422375-2024-00016
Device Sequence Number15252781
Product Code EFB
UDI-Device Identifier04589551385348
UDI-Public04589551385348
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
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) 06/20/2024
Report Date (Section F) 06/07/2024
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 NumberZ890L
Device Catalogue NumberPA23720001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/30/2024
Device Age6 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/07/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/21/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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