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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 09/10/2019
Event Type  malfunction  
Event Description
The user facility reported the device overheated during a procedure.The patient incurred an unspecified burn to the upper lip during the event.The procedure was completed successfully with no surgical delay or medical intervention.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported the device overheated during a procedure.The patient incurred an unspecified burn to the upper lip during the event.The procedure was completed successfully with no surgical delay or medical intervention.
 
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Brand Name
MICRODRILL STRAIGHT ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9254938
MDR Text Key164300067
Report Number0001811755-2019-03566
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/31/2020
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 No Information
Device Model Number5100015250
Device Catalogue Number5100015250
Device Lot Number17180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Initial Date Manufacturer Received 10/11/2019
Initial Date FDA Received10/30/2019
Supplement Dates Manufacturer Received10/11/2019
Supplement Dates FDA Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age11 YR
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