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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK HANDPIECE, AIR-POWERED, DENTAL

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NAKANISHI INC. NSK HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Model Number TI-MAX X450 5H
Device Problems Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907); Noise, Audible (3273)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
Nakanishi is trying to obtain information about the patient. The same adverse event in this report has been reported to the fda separately by the initial importer, (b)(4), under report number (b)(4).
 
Event Description
On december 21, 2020, nakanishi became aware of a malfunction of an nsk handpiece through a complaint input into the complaint database by a distributor (nsk america). Details are as follows: the event occurred on (b)(6) 2020. A dentist was performing a crown procedure using the ti-max x450 5h handpiece (serial no. (b)(4)). During the procedure, the device made a popping noise and the head of the handpiece came off in the patient's mouth. The glass rod broke and metal pieces fell into the patient's mouth. The dentist removed the pieces and there was no effect on the patient. The patient had a follow up visit with the dentist on (b)(4) 2020, and the patient has had no complications and does not require any medical treatment.
 
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Brand NameNSK
Type of DeviceHANDPIECE, 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
kenneth block
800 e campbell rd.
suite 202
richardson, TX 75081
9724809554
MDR Report Key11184028
MDR Text Key245730953
Report Number9611253-2021-00003
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Dentist
Type of Report Initial,Followup,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTI-MAX X450 5H
Device Catalogue NumberP1093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/18/2021 Patient Sequence Number: 1
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