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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVIGATION KIT FOR NAVSUITE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO NAVIGATION KIT FOR NAVSUITE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 7700-009-010
Device Problems Imprecision (1307); Malposition of Device (2616)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/21/2015
Event Type  Injury  
Manufacturer Narrative
Please refer to mfr. Report number 0002249697-2015-04079 for a report filed on the concomitant device, triathlon p/a cr beaded #4l (catalog number: 5517f401, serial number: (b)(4)).
 
Event Description
It was reported that during a bilateral triathlon knee procedure conducted at the user facility, the navigation screen blinked white as the left femur cut was made. On a postoperative x-ray, it was confirmed that the left femur was cut in 6 degrees valgus. A revision surgery of the left knee was completed successfully, approximately one week later.
 
Manufacturer Narrative
The reported event that the femur was cut in 6° valgus could not be confirmed based on the provided postoperative x-rays. Instead, the x-rays show a leg alignment of about 6° valgus. However, upon review of the log files and patient files, there were no clear indications that the registration may have been performed poorly or that the navigation system did not function properly.
 
Event Description
It was reported that during a bilateral triathlon knee procedure conducted at the user facility, the navigation screen blinked white as the left femur cut was made. On a postoperative x-ray, it was confirmed that the left femur was cut in 6 degrees valgus. A revision surgery of the left knee was completed successfully, approximately one week later.
 
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Brand NameNAVIGATION KIT FOR NAVSUITE
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 Key5361938
MDR Text Key35725500
Report Number0001811755-2016-00052
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7700-009-010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/12/2016 Patient Sequence Number: 1
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