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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER MACHTOU PLUGGER; PLUGGER, ROOT CANAL, ENDODONTIC
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DENTSPLY MAILLEFER MACHTOU PLUGGER; PLUGGER, ROOT CANAL, ENDODONTIC Back to Search Results
Catalog Number S214301250100
Device Problems Component Falling (1105); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
In this event, it was reported that a machtou plugger separated; the broken piece could not be retrieved.However, treatment is not yet complete.
 
Manufacturer Narrative
Therefore, because the broken piece is still in the pt's canal, 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
MACHTOU PLUGGER
Type of Device
PLUGGER, ROOT CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
ballaigues
SZ 
Manufacturer Contact
helen lewis
21w philadelphia st, ste 60
sesquehanna commerce ctr w
york, PA 17401
7178457511
MDR Report Key4795831
MDR Text Key5858850
Report Number8031010-2015-00013
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberS214301250100
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/30/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/23/2015
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) Other;
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