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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.
 
Manufacturer Narrative
Additional information added for.Device evaluation: follow-up report submitted to document device evaluation results.
 
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 Name
STRYKER NAV3I(TM) PLATFORM
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7818785
MDR Text Key118305503
Report Number0001811755-2018-01618
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327004175
UDI-Public07613327004175
Combination Product (y/n)N
PMA/PMN Number
K162937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7700-800-000
Device Lot Number3.0-13/14
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/06/2018
Initial Date FDA Received08/27/2018
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received02/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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