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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Event Description
The user facility reported the device overheated during a procedure, leading to a burn incurred by the patient. Although requested, there was no information available regarding surgical delay, medical intervention, and any additional adverse consequence.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8785038
MDR Text Key150843332
Report Number0001811755-2019-02273
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Device Lot Number16308
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 Received01/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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