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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL Back to Search Results
Catalog Number 2296101316
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during a dental extraction surgery, the bur broke at the cutting end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
Event Description
It was reported that during a dental extraction surgery, the bur broke at the cutting end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
Investigation results indicate that contact with metal along with off axis cutting could have contributed to the bur breaking.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with a cutting accessory.Applying excessive pressure, especially during high operating speeds, may cause the cutting accessory to bend significantly or fracture.Failure to comply may cause tissue damage, loss of tactile control or the ejection of cutting accessory pieces at a high velocity." the quality investigation is complete.
 
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Brand Name
1.6MM 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 Key7818622
MDR Text Key118305612
Report Number0001811755-2018-01617
Device Sequence Number1
Product Code EJL
UDI-Device Identifier04546540046239
UDI-Public04546540046239
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2023
Device Catalogue Number2296101316
Device Lot Number18043017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Date Manufacturer Received10/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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