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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVSUITE®3 UPGRADE W670/SPC-2 TO SPC-3; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAVSUITE®3 UPGRADE W670/SPC-2 TO SPC-3; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 7700-009-102
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2018
Event Type  malfunction  
Event Description
It was reported that while using navigation spine map software at the user facility the system was freezing, and delaying image guidance to the user.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that while using navigation spine map software at the user facility the system was freezing, and delaying image guidance to the user.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
NAVSUITE®3 UPGRADE W670/SPC-2 TO SPC-3
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7903153
MDR Text Key121504822
Report Number0001811755-2018-01671
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K162937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7700-009-102
Device Lot NumberVERSION 3.1-14
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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