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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL RADIX ANKER POST TITANE 1; POST, ROOT CANAL
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MAILLEFER INSTRUMENTS HOLDING SARL RADIX ANKER POST TITANE 1; POST, ROOT CANAL Back to Search Results
Catalog Number C193T00000100
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Event Description
It was reported that a radix anchor post broke and cannot be removed by the dentist.Additional information has been requested.
 
Manufacturer Narrative
The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.The brand name and catalog number have been corrected in this follow-up report.
 
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Brand Name
RADIX ANKER POST TITANE 1
Type of Device
POST, ROOT CANAL
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 Key13333685
MDR Text Key286576867
Report Number8031010-2022-00420
Device Sequence Number1
Product Code ELR
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberC193T00000100
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/20/2021
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage A
Patient Sequence Number1
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