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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS Back to Search Results
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 09/21/2017
Event Type  Injury  
Event Description
The user facility reported that the device overheated during a procedure to extract 4 wisdom teeth. The procedure was completed successfully without delay; however, the patient was burned in the inner cheek (2 cm x 1 cm) which resulted in the patient receiving 2 stitches.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceSMALL BONE POWERED SURGICAL SYSTEMS
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7160916
MDR Text Key96325752
Report Number0001811755-2018-00005
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Device Lot Number14261
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/03/2018 Patient Sequence Number: 1
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