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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.1MM CROSS-CUT FISSURE ROUND TIP CARBIDE BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 2.1MM CROSS-CUT FISSURE ROUND TIP CARBIDE BUR; BUR, DENTAL Back to Search Results
Catalog Number 2296101421
Device Problem Vibration (1674)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
 
Event Description
It was reported that during a procedure on the wisdom tooth, three burs made noise and was moving.It was also reported that there was a forty-five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the second bur.
 
Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.
 
Event Description
It was reported that during a procedure on the wisdom tooth, three burs made noise and was moving.It was also reported that there was a forty-five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the second bur.
 
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Brand Name
2.1MM CROSS-CUT FISSURE ROUND TIP CARBIDE BUR
Type of Device
BUR, DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8711802
MDR Text Key148413085
Report Number0001811755-2019-02078
Device Sequence Number1
Product Code EJL
UDI-Device Identifier04546540046277
UDI-Public04546540046277
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2022
Device Catalogue Number2296101421
Device Lot Number17205017
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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