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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION PB FIBER OPTIC HANDPIECE, AIR-POWERED, DENTAL

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DENTSPLY PROFESSIONAL MIDWEST TRADITION PB FIBER OPTIC HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 790045
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
See the attached investigation summary.
 
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 results are not available 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 tradition handpiece while in use. The reported complaint did not result in an injury or need for intervention.
 
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Brand NameMIDWEST TRADITION PB FIBER OPTIC
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer (Section G)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7117225
MDR Text Key263386243
Report Number1419322-2017-00302
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963050
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 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number790045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2017
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 Reuse

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