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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 12/14/2017
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight were unavailable from the attached journal article or by the authors. Patient age and patient sex not made available the attached journal article or by the authors. The article reports that the mean patient age was 49 and the consisted of male patients in the study. Therefore 49 years old and male were used. Event date is approximated. Date provided is when the journal article was accepted. Citation: christopher j. Kleck, md, christopher johnson, md, michelle akiyama, bs, evalina l. Burger, md, christopher j. Cain, md, and vikas v. Patel, md. One-step minimally invasive pedicle screw instrumentation using o-arm and stealth navigation. (2018). Clin spine surg 2018;00:000¿000. The exact system information could not be determined as it was not provided. However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed. Device udi not provided as actual product used for this study is unknown. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. 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 system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Not returned by customer.
 
Event Description
The attached journal article was forwarded by a medtronic representative. Use of the navigation system was reported. In total, 35 adult patients (187 screws) underwent lumbar surgery with pedicle screw placement using the 1- (8 patients/48 screws) or 2-step (27 patients/139 screws) technique. Complications associated with instrumentation were noted. Pedicle screw position was evaluated. 22 male and 13 female per table 1. Average age was 49 year old. Of 187 screws placed, 181 (96. 8%) were found to be fully contained within the pedicle (grade 1) and 4 (2. 1%) had a breach of <2mm. In the 1-step technique, no screws were malpositioned. One screw at s1 with inadequate fixation was replaced with a screw 1mm larger in diameter. In the 2-step technique, 2 screws (1. 06% overall) were revised due to inferior breach of the pedicle. No neurological sequelae were noted. Also, 1 screw was deemed too long at s1 and was replaced with a shorter screw. None of the revised pedicle screws caused neuromonitoring changes and the breaches were found intraoperatively on 3d imaging. Using imaging system and navigation system with minimally invasive surgical technology for placement of posterior spinal instrumentation is safe, effective, and limits radiation exposure.
 
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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
navigation customer quality
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7357531
MDR Text Key103037039
Report Number1723170-2018-01211
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 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/21/2018
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: 03/21/2018 Patient Sequence Number: 1
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