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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK DENTAL HANDPIECE

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NAKANISHI INC. NSK DENTAL HANDPIECE Back to Search Results
Model Number X450 5H
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  Injury  
Event 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.
 
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Brand NameNSK
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
MDR Report Key11179757
MDR Text Key230327492
Report Number1422375-2021-00003
Device Sequence Number1
Product Code EFB
UDI-Device Identifier04560264532472
UDI-Public04560264532472
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberX450 5H
Device Catalogue NumberP1093001
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? Yes
Date Report Sent to FDA01/15/2021
Distributor Facility Aware Date12/21/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2021 Patient Sequence Number: 1
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