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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PROROOT MTA; RESIN, ROOT CANAL FILLING
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DENTSPLY TULSA DENTAL SPECIALTIES PROROOT MTA; RESIN, ROOT CANAL FILLING Back to Search Results
Catalog Number PROROOTMC2W
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Inflammation (1932); Complaint, Ill-Defined (2331)
Event Type  Injury  
Event Description
In this event it was reported that several pts experienced periapical inflammation and tooth discoloration after using proroot mta.In each case, the proroot mta was removed and replaced with another material.
 
Manufacturer Narrative
There were no further issues after the material was replaced.Therefore, because medical intervention was required, this event is reportable per 21 cfr part 803.The device is available for eval, though results are not available as of this report.Eval results will be submitted as they become available.
 
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Brand Name
PROROOT MTA
Type of Device
RESIN, ROOT CANAL FILLING
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
johnson city TN
Manufacturer Contact
helen lewis
221 w philadelphia st, ste 60
susquehanna commerce center w
york, PA 17401
7178457511
MDR Report Key4495732
MDR Text Key5565466
Report Number2320721-2015-00001
Device Sequence Number1
Product Code KIF
Combination Product (y/n)N
PMA/PMN Number
K011009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPROROOTMC2W
Device Lot Number10003597
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/26/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/09/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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