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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 7700-800-000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2018
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility prior to the start of a surgical procedure the system was freezing, which can lead to inaccuracy. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand NameSTRYKER NAV3I(TM) PLATFORM
Type of DeviceORTHOPEDIC 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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7818785
MDR Text Key118305503
Report Number0001811755-2018-01618
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7700-800-000
Device Lot Number3.0-13/14
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 Received02/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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