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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 Device Operates Differently Than Expected (2913)
Patient Problems Perforation (2001); Iatrogenic Source (2498)
Event Date 02/28/2015
Event Type  Injury  
Manufacturer Narrative
Patient identifier not available on article. Patient age was based on the article information. Mean age was 64. 6 years. Therefore, 65 years was used. Patient sex was determined based on the article information which 95 men and 56 women. Therefore, male was selected. Patient weight not available on attached article. Event date is approximated based on the attached journal accepted date, which is (b)(6) 2015. B5) citation: masashi uehara, jun takahashi, shota ikegami, et al. Optimal cervical screw insertion angle determined by means of computed tomography scans pre- and postoperatively. (2017). The spine journal 17 (2017) ;190-195 http://dx. Doi. Org/10. 1016/j. Spinee. 2016. 08. 025 device serial number was not unavailable on attached journal article. 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 navigation. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
Event Description
Medtronic representative reviewed the attached article on (b)(6) 2017, and forwarded it for evaluation for potential complaint reporting with intraoperative navigation system. This study aimed to understand the perforation tendencies of cervical pedicle screw (cps) insertion angles in relation to anatomical pedicle transverse angle (pta). The study enrolled 151 consecutive patients (95 men and 56 women, with a mean age of 64. 6 years). The anatomical pta and cps insertion angles were evaluated by axial ct images. The medical records of 151 consecutive patients who underwent cps insertion using a ct-based navigation system were reviewed. We examined the relationships between pta and cps insertion angle on axial ct images according to vertebral level. For this study, a screw insertion status of grade 2 or 3 was regarded as a perforation. A total of 676 screws were inserted into c2¿c7 with the assistance of a ct-based navigation system. Among these, 46 screws (6. 8%) had g3 perforated and 137 screws (20. 3%) had g2+3 perforated either medially or laterally. No clinically significant complications, such as vertebral artery, spinal cord, or nerve root injury, were caused by the perforations. A ct-based navigation system can be employed to achieve more accurate and safer pedicle screw insertion than free-hand technique. However, cps perforation can still occur at a low incidence due to paravertebral muscle (pvm) pressure, especially when the screw insertion angle is large. In such cases, pvm pressure on the screwdriver contributes to lateral perforation despite confirmation that the screw hole is not perforated by sounding, and insertion may not be perfectly accurate even if navigation is used. When screw direction cannot be adequately set in a medial orientation, an external skin incision is advised to insert the cps as deeply and at a small insertion angle as possible. From 2004, a new navigation system was adopted but perforation rate increased, possibly due to more trauma cases being treated by less experienced spine surgeons. With the next version system, the perforation rate decreased, likely because of a dramatic improvement in image quality and registration accuracy.
 
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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 Key7088287
MDR Text Key93895792
Report Number1723170-2017-04976
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
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 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
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 Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/06/2017 Patient Sequence Number: 1
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