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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3(R) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3(R) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 7700-700-000
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event. Log files were not available for investigation.
 
Event Description
It was reported that the navigation system is crashing at the user facility. A system crashing could necessitate professional medical or surgical intervention (to prevent permanent impairment. There is no known associated procedure. No significant delays or known impact to the patient were associated with the event.
 
Event Description
It was reported that the navigation system is crashing at the user facility. A system crashing could necessitate professional medical or surgical intervention (to prevent permanent impairment. There is no known associated procedure. No significant delays or known impact to the patient were associated with the event.
 
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Brand NameSTRYKER NAV3(R) PLATFORM
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7145972
MDR Text Key192078164
Report Number0001811755-2017-02490
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162929
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7700-700-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
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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