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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PRO-POST DRILL; DRILL, DENTAL, INTRAORAL
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DENTSPLY TULSA DENTAL SPECIALTIES PRO-POST DRILL; DRILL, DENTAL, INTRAORAL Back to Search Results
Catalog Number POSTD2
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/07/2014
Event Type  malfunction  
Event Description
In this event it was reported that a pro-post drill broke during use.The broken piece was incorporated into the filling.
 
Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable 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.
 
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Brand Name
PRO-POST DRILL
Type of Device
DRILL, DENTAL, INTRAORAL
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
johnson city TN
Manufacturer Contact
helen lewis
221 w. philadelphia st. ste. 60
york, PA 17401
7178457511
MDR Report Key4234838
MDR Text Key5002912
Report Number2320721-2014-00007
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPOSTD2
Device Lot Number6020714
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/20/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/07/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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