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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015252
Device Problems Fluid Leak (1250); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 1 event was reported for this quarter. Product return status: 1 device investigation type has not yet been determined. 1 device was not labeled for single-use. 1 device was not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device reportedly overheated and was leaking. 1 event had the patient receive a burn.
 
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Brand NameMICRO DRILL SERIES ANGLED 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 Key10329737
MDR Text Key200774985
Report Number0001811755-2020-01838
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5100015252
Device Catalogue Number5100015252
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? No
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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