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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER ZEKRYA BUR; DENTAL BUR
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DENTSPLY MAILLEFER ZEKRYA BUR; DENTAL BUR Back to Search Results
Catalog Number E015134100000
Device Problem Failure To Service (1563)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
In this event it was reported that a zekrya burr separated during a surgical operation; as of this mdr evaluation, the separated piece remains inside the bone of the gum, visible on x-ray.
 
Manufacturer Narrative
Per condition #1 of (b)(4), events meeting the definition of a serious injury are required to be reported.Therefore, because of the possibility that the separated piece will need to be removed surgically, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
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Brand Name
ZEKRYA BUR
Type of Device
DENTAL BUR
Manufacturer (Section D)
DENTSPLY MAILLEFER
ballaigues
SZ 
Manufacturer Contact
helen lewis
221 w. philadelphia st., ste. 60
susquehanna commerce center w.
york, PA 17410
7178457511
MDR Report Key4746097
MDR Text Key5884269
Report Number8031010-2015-00011
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE015134100000
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2015
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) Required Intervention;
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