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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM OVAL CARBIDE BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 4.0MM OVAL CARBIDE BUR; BUR, DENTAL Back to Search Results
Catalog Number 0277010062
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that while testing, the bur broke.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
Investigation results indicate the bur may have fractured due to overload conditions, however without further details concerning the testing involved, the root cause cannot be determined.The quality investigation is complete.
 
Event Description
It was reported that while testing, the bur broke.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
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Brand Name
4.0MM OVAL CARBIDE BUR
Type of Device
BUR, DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key6685345
MDR Text Key79027078
Report Number0001811755-2017-01360
Device Sequence Number1
Product Code EJL
UDI-Device Identifier4546540050656
UDI-Public(01)4546540050656
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2017
Device Catalogue Number0277010062
Device Lot Number12125107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/06/2017
Initial Date FDA Received07/04/2017
Supplement Dates Manufacturer Received11/22/2017
Supplement Dates FDA Received11/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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