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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARB.B.CAV.CONE SQUARE FG 012; BUR, DENTAL
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CARB.B.CAV.CONE SQUARE FG 012; BUR, DENTAL Back to Search Results
Catalog Number E013834101200
Device Problem Break (1069)
Patient Problems Tissue Damage (2104); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Per condition #1 of exemption e2006004, events meeting the definition of a serious injury are required to be reported.Therefore, because pulp hole is larger than before, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
 
Event Description
In this event it was reported that a carbide bur broke during use causing the pulp hole to be slightly larger than before.The problem was solved.Information regarding potential patient's injury pending.
 
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.
 
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Brand Name
CARB.B.CAV.CONE SQUARE FG 012
Type of Device
BUR, DENTAL
MDR Report Key10825874
MDR Text Key215890602
Report Number8031010-2020-00235
Device Sequence Number1
Product Code EJL
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE013834101200
Device Lot Number201906
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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