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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problems Perforation (2001); Iatrogenic Source (2498)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the article. Event date is approximated based on the article's accepted date. Therefore (b)(6) 2016 was used. Citation: daipayan guha, md, raphael jakubovic, msc, shaurya gupta, md et al. Spinal intraoperative three-dimensional navigation: correlation between clinical and absolute engineering accuracy. 2017. The spine journal 1723170-2017-0; 2017, 489-498. Http://dx. Doi. Org/10. 1016/j. Spinee. 2016. 10. 020. Device serial number was estimated based on the site and study duration indicated on the article. Actual device information is unavailable. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's intraoperative imaging and navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
Event Description
Medtronic representative reviewed attached article and forwarded it for evaluation for potential complaint reporting with intraoperative imaging system and navigation system. This study aimed to characterize the correlation between clinical pedicle screw accuracy, based on postoperative imaging, and absolute quantitative navigation accuracy. This is a retrospective review of a prospectively collected cohort. Thirty (30) patients undergoing first-time posterior cervical-thoraciclumbar-sacral instrumented fusion±decompression, guided by intraoperative three-dimensional computer-assisted navigation (can). All patients underwent posterior cervical-thoracic-lumbarsacral instrumented fusion with pedicle screw constructs, with or without decompression, for predominantly traumatic, degenerative, or neoplastic pathologies. Procedures were performed at (b)(6) health sciences centre by a single surgeon, with or without trainee assistance, from may 2014 to february 2015. Clinical or radiographic screw accuracy (heary and 2 mm classifications) and absolute quantitative navigation accuracy (translational and angular error in axial and sagittal planes). This research reviewed a prospectively collected series of 209 pedicle screws placed with can guidance. Each screw was graded clinically by multiple independent raters using the heary and 2 mm classifications. Clinical grades were dichotomized per convention. The absolute accuracy of each screw was quantified by the translational and angular error in each of the axial and sagittal planes. Acceptable screw accuracy was achieved for significantly fewer screws based on 2 mm grade versus heary grade (92. 6% vs. 95. 1%, p
=
. 036), particularly in the lumbar spine. Inter-rater agreement was good for the heary classification and moderate for the 2 mm grade. Radiographic classifications of pedicle screw accuracy vary in sensitivity across spinal levels, as well as in inter-rater reliability. Correlation between clinical screw grade and absolute navigation accuracy is poor, as surgeons appear to compensate for navigation registration error. Future studies of navigation accuracy should report absolute translational and angular errors. Clinical screw grades based on postoperative imaging may be more reliable if performed in multiple by radiologist raters. Of 209 screws, with 932 combined heary grades from five independent reviewers, 95. 1% were rated as acceptable. On the 2-mm grading scale, from four independent reviewers assessing the same dataset, significantly fewer screws were rated as acceptable, at 92. 6%. We theorized that the lack of observed correlation between clinical screw grade and absolute navigation accuracy may be due, in part, to surgeon compensation for perceived misalignment of virtual and anatomical intended screw entry points, based on surgeon visualization and knowledge of anatomical landmarks. For instance, a ¿perfect¿ entry point as shown by the navigation system, which is felt by the surgeon to be excessively lateral based on anatomical knowledge, may lead the surgeon to compensate by medializing their screw trajectory. In conclusion, the study stated that although can is a useful intraoperative adjunct, it cannot and should not replace dedicated subspecialty training, which affords the experience and anatomical knowledge required to identify and compensate for navigation errors.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
koko tyler
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7082993
MDR Text Key93731563
Report Number1723170-2017-04566
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2011
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: 12/05/2017 Patient Sequence Number: 1
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