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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem Imprecision (1307)
Patient Problems Perforation (2001); Iatrogenic Source (2498)
Event Date 06/25/2009
Event Type  Injury  
Manufacturer Narrative
Patient identifier not available on attached journal article. Patient age was indicated on attached journal article as between 41 and 84. Therefore, (b)(6) was used. Patient sex was indicated on attached journal article for 18 men and 16 women. Therefore, male was used. Patient weight not available on attached journal article. Event date is approximated and based on the accepted date which was (b)(6) 2009. Citation: jonathan m. Bledsoe, mda, doug fenton, mdb, jeremy l. Fogelson, mda, and eric w. Nottmeier, md. Accuracy of upper thoracic pedicle screw placement using three-dimensional image guidance. (2009). The spine journal 9; 817¿821; doi:10. 1016/j. Spinee. 2009. 06. 014. Device serial number was estimated by attached journal article which the study was performed between october 2002 and october 2008. Udi not required as this product is no longer manufactured. 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 system. 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 november 7, 2017, and forwarded it for evaluation for potential complaint reporting with intraoperative navigation system. The accuracy of pedicle screw placement in the first three thoracic vertebrae was evaluated using postoperative thin-section computed tomography (ct) scans of the cervicothoracic region. There was thirty-four consecutive patients underwent cervicothoracic instrumentation and fusion for a total of 150 pedicle screws placed in the first three thoracic vertebrae. Posterior cervicothoracic fusion was performed between october 2002 and october 2008. The patients included 18 men and 16 women between 41 and 84 years of age. The most common indication for surgery in this series was cervical deformity. Other indications included trauma, tumor, myelopathy, and infection. Cervicothoracic constructs were extended to one of the first three thoracic vertebrae, with a total of 150 screws placed (t1568, t2554, t3528). The ¿¿in-out-in¿¿ technique was used for the placement of pedicle screws into extremely narrow pedicles. This technique allows for lateral cortical purchase of a pedicle with a more medial trajectory, so the tip of the pedicle screw ends up in the vertebral body. Exploitation of this maneuver permits the use of wider screws in a more medial trajectory and can be an advantage to an extremely narrow screw having to be used in a straight trajectory or when the pedicle does not have the anatomy to accommodate the smallest diameter screw available. The pedicle entry point is just lateral to the normal pedicle entry point, and thus the screw engages the lateral aspect of the pedicle. In the midpoint of the pedicle, the screw trajectory is extrapedicular while engaging the lateral cortex of the pedicle before entry into the vertebral body. These intentional breaches were necessary to perform the procedure and thus not counted in the breach analysis. Postoperative follow-up of these patients ranged from 1 to 24 months with an average of 10 months. In this system, a breach of less than 2 mm is considered a grade 1 breach, a breach of 2 to 4 mm is considered a grade 2 breach, and a breach of more than 4 mm is considered a grade 3 breach. Direction of perforation was also noted including anterior bony perforation by the tip of the screw. Grading of the ct scans revealed 140 (93. 3%) out of 150 screws completely within the desired pedicle. All 10 pedicle violations were grade 1. During the postoperative follow-up period, five patients experienced operative complications: two wound dehiscences, two pseudoarthroses, and one wound dehiscence and pseudoarthrosis. No patient experienced complications associated directly with the placement of the screws or the use of intraoperative image guidance. In conclusion, the use of 3d intraoperative image-guided techniques has shown increased accuracy of pedicle screw placement throughout the spine. Advantages of this technology include safe and accurate placement of spinal instrumentation with little to no radiation exposure to the surgeon and operating room staff.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE 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 Key7097560
MDR Text Key94162980
Report Number1723170-2017-05010
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
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
Date Device Manufactured03/10/2008
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: 12/07/2017 Patient Sequence Number: 1
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