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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-008-000
Device Problem Disassembly (1168)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2016
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility, a button was found to be missing from the device. It was reported that no patient involvement or procedural delays are associated with this event.
 
Manufacturer Narrative
The reported event that there was no button on the device was confirmed through the device inspection. It was observed that the screw at the select button was broken off and the select button was missing. Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that testing conducted at the user facility a button was found to be missing from the device. It was reported that no patient involvement or procedural delays are associated with this event.
 
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Brand NameINSTRUMENT TRACKER
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6150709
MDR Text Key61606761
Report Number0001811755-2016-02818
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6007-008-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2014
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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