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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL Back to Search Results
Catalog Number 2296100212
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/26/2019
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 the bur broke during a molar removal.It was further reported that the broken piece was retrieved from the patient.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
Event Description
It was reported that the bur broke during a molar removal.It was further reported that the broken piece was retrieved from the patient.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
Investigation results indicate that the bur broke as a result of being incorrectly loaded into the attachment.The instructions for use (ifu) of handpieces associated with this device provides detailed instructions for loading the cutting accessories and warn the user against this type of use: "warning: make sure the safety line on the cutting accessory is not visible after the shield is installed.Failure to comply may allow the cutting accessory to eject from the handpiece or bend.The quality investigation is complete.
 
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Brand Name
1.2MM CROSS-CUT FISSURE CARBIDE BUR
Type of Device
BUR, DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8629557
MDR Text Key145693110
Report Number0001811755-2019-01775
Device Sequence Number1
Product Code EJL
UDI-Device Identifier04546540045874
UDI-Public04546540045874
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 07/03/2019
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 Date04/01/2022
Device Catalogue Number2296100212
Device Lot Number17117017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Initial Date Manufacturer Received 04/26/2019
Initial Date FDA Received05/21/2019
Supplement Dates Manufacturer Received06/28/2019
Supplement Dates FDA Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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