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

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.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL 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 Key: 7555482
• MDR Text Key: 109610483
• Report Number: 1723170-2018-02322
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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 Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• 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 Received: 05/14/2018
• 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