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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Perforation (2001)
Event Date 12/03/2012
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight were unavailable from the journal article or by the authors. Patient age and patient sex not made available the journal article or by the authors. The article reports that the mean patient age was (b)(6) years old and the consisted of female patients in the study. Therefore (b)(6) years old and female were used. Event date is approximated. The study for this journal article was performed between 2011 and 2012. Therefore, the last day of 2012 was used for event date. Citation: noshchenko a, cain c, zaghloul k et al. Pedicle screw placement assisted by 3d imaging (o-arm system with stealthstation® software) versus free-hand technique for multilevel posterior thoracolumbar fusion. Current orthopaedic practice. 2018; 29;2:1-6. Doi: 10. 1097/bco. 0000000000000601. 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. Per author, intraoperative use of the imaging device/surgical navigation system allows decreased risk of the pedicle screw misplacement and corresponding perioperative complications during multilevel posterior instrumented thoracolumbar fusion in comparison to the free-hand technique. These benefits are more obvious at the thoracic level of the spine than at the lumbar level. The imaging device/surgical navigation is most efficient in the prevention of medial and lateral breaches during pedicle screw placement. For multilevel thoracolumbar fusion, the imaging device/surgical navigation system-assisted pedicle screw placement is preferable at thoracic levels, while the free-hand technique may be used in the lumbar spine. Theoretically this strategy allows minimization of the following undesirable outcomes: risk of the pedicle screw misplacement and corresponding perioperative complications, radiation exposure of patient, and extra operation time. However, this strategy is applicable if there are no specific indications for the navigation with imaging system at the lumbar spine and experience of surgeons in using of a free-hand technique is appropriate. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Device not returned by customer.
 
Event Description
The journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. Medical records and radiographic data of spinal surgical interventions consecutively conducted between 2011 and 2012 in one hospital were retrospectively analyzed. Collected data were allocated to two study groups: cases in which pedicle screw insertion was performed with assistance of the imaging device/surgical navigation system (navigated); and (2) cases in which pedicle screws were placed using a free-hand technique (nonnavigated). Screws were placed according to the surgeon¿s preference or comfort level with the technique. The following classification of the pedicle screw misplacements (breaches) was applied: grade 1, pedicle screw completely contained within the pedicle and vertebral body (no breach, figure 1); grade 2, any part of the screw extended beyond the cortex of the pedicle or vertebral body but not more than 2mm (mild breach; figure 2) grade 3, pedicle screw extended between 2-4mm (medium breach); and grade 4, screw extension exceeded 4mm (severe breach). Seventy cases matched to the inclusion or exclusion criteria were included into the study. All operations were performed by the same team of experienced surgeons. Forty-one patients (12 male and 29 female) were operated using the imaging device/surgical navigation system and thus were assigned to the navigated group; and 29 patients (10 male and 19 female) were operated without navigation using a free-hand technique, and thus assigned to the nonnavigated group. The mean age in the navigated group was 59 (sd, 9. 3) years, and the mean age in the nonnavigated group was 65 (sd, 9. 2) years. Table 3 showed the risk of breach associated with use of navigation system which 10 cases of grade ii (< 2mm), 3 cases of grade iii (2-4mm) and 2 cases of grade iv (> 4mm). Table 5 indicated the risk of perioperative complications with use of navigation which 2 cases of deep infection, 1 case of pedicle fracture and 1 case of hardware failure.
 
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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 Key7555482
MDR Text Key109610483
Report Number1723170-2018-02322
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 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
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 Received05/14/2018
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: 05/30/2018 Patient Sequence Number: 1
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