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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS PLUS SPK HANDPIECE, AIR-POWERED, DENTAL

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DENTSPLY PROFESSIONAL MIDWEST STYLUS PLUS SPK HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 792430
Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that the cap unscrewed from a stylus plus handpiece while in use. The reported complaint did not result in an injury or need for intervention.
 
Manufacturer Narrative
Received the handpiece in pieces, both bearings were off of the turbine shaft, cap was off also. The only visible damage was to the turbine which with both bearings in pieces. The cap was sticking, did not press in and out consistently, evenly. There was no thread damage to either the cap or the inside of the head. I tightened down the cap and it was not cross threaded either. The chuck pusher may have been pressed in and not released.
 
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Brand NameMIDWEST STYLUS PLUS SPK
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer (Section G)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, D-646 25
GM D-64625
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7518967
MDR Text Key108874558
Report Number1419322-2018-00037
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 07/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number792430
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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