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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL UNKNOWN; FILE, PULP CANAL, ENDODONTIC
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MAILLEFER INSTRUMENTS HOLDING SARL UNKNOWN; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number provided was not found to conduct retained-product testing and/or dhr review.
 
Event Description
It was reported that an unknown brand endodontic file broke during use.The event outcome is unknown as of this mdr evaluation.
 
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Brand Name
UNKNOWN
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ  CH-1338
Manufacturer (Section G)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ   CH-1338
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key12915352
MDR Text Key281588301
Report Number8031010-2021-00369
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot Number083509
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/02/2021
Date Manufacturer Received11/02/2021
Type of Device Usage Unknown
Patient Sequence Number1
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