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Adverse Event Report

DENTSPLY TULSA A FLEXOFILE DENTAL HAND FILE   back to search results
Catalog Number 6713731
Event Date 11/26/2003
Event Type  Injury   Patient Outcome  Other;
Event Description

The doctor reported separating a file in the patient's tooth during a dental procedure. The doctor elected to extract the tooth to complete the procedure.

 
Manufacturer Narrative

In this incident there was a report a injury to the pt, a tooth needed to be extracted after a file broke in the tooth. The file malfunctioned. Options available for the management of a broken instrument include observation only, attempts at nonsurgical removal, periradicular surgery, intentional replantation, root resection and extraction. The latter four involve surgical intervention and are only done if signs and symptoms warrant. Expert opinion on file indicates that surgical treatment is often unnecessary and inadvisable and should not be performed "automatically" because of the file breakage but only if other alternative treatments are not viable or successful and signs and symptoms warrant. Since the doctor opted to do an extraction the same day, user misjudgement and inappropriate use of surgical intervention cannot be ruled out. In other instances, a broken file has caused or contributed to surgical intervention and therefore, this incident should be reported.

 
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Brand NameFLEXOFILE
Type of DeviceDENTAL HAND FILE
Baseline Brand NameFLEXOFILE
Baseline Generic NameDENTAL HAND FILE
Baseline Catalogue Number6713731
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DENTSPLY TULSA A
608 rolling hills dr
johnson city TN 37604
Manufacturer (Section D)
DENTSPLY TULSA A
608 rolling hills dr
johnson city TN 37604
Manufacturer (Section G)
DENTSPLY MAILLEFER
*
ballaigues
SWITZERLAND CH-1338
Manufacturer Contact
patricia kihn
221 w. phila. st., ste 60
susquehanna commerce ctr w
york , PA 17404
(717) 845 -7511
Device Event Key503488
MDR Report Key514476
Event Key488114
Report Number8031010-2004-00116
Device Sequence Number1
Product CodeEKS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6713731
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/26/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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