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 Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Iatrogenic Source (2498)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

No patient id or weight was provided by the author(s).Feng sw, yang yj, li cz, lin mc, chung tt, chen yh.Accuracy of spinal screw fixation using intraoperative o arm navigation: consecutive series of 118 screws.J med sci 2016;36(1):6 13 doi: 10.4103/1011-4564.177169.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.The article concludes, "o-arm 3d navigation achieves a relatively high accuracy of pedicle and lateral mass screw implantation.The accumulation of experience for o-arm 3d ct during initial learning curve is still warranted to promote the accuracy of screws position and shorten operation time." furthermore, the article states "the workstation calculated multiplanar and 3d images, and the surgeons could use these realtime images and reference-guiding device to decide the trajectory of the screws.A ball-tipped feeler probe was used to make the screw tract.Even though the medtronic screw system has its own navigation screwdriver, we implanted the screws free hand along the pathway made by the navigation probe." thus, the screws were not navigated when being driven into the pedicle.

Event Description

Per attached article entitled, accuracy of spinal screw fixation using intraoperative o-arm navigation: consecutive series of 118 screws, the study aims to evaluate the accuracy of o-arm 3d navigation-assisted spinal implantation.A total of 118 transpedicle/lateral mass screws in 17 consecutive patients were placed with o-arm 3d computed tomography (ct) imaging navigation.Screw placement accuracy, visual analogue scale (vas), and operation time were assessed.O-arm 3d navigation included 96 pedicle screws and 22 lateral mass screws.Results: the accuracy rate of screw implantation was (b)(4) without breach (grade 0), whereas (b)(4) breached between 2 and 4 mm (grade 2).In the cervical spine, 12 pedicle screws were placed in 4 patients; (b)(4) exhibited a grade 2 breach in one patient, who developed a new neurological deficit and required revision.In the lumbosacral spine, (b)(4) exhibited a grade 2 breach in 2 patients.The mean +/- standard deviation vas of the patients in postoperative and preoperative status was 1.47 +/-.50 and 3.58 +/- 1.00, respectively.The operation time was significantly longer in o-arm navigation than in c-arm guidance (426.5 +/- 180.4 vs.317.9 +/- 133.6 min, p < 0.05).Complications: notably, there were no cerebrospinal fluid (csf) leaks or vascular injuries in this series.However, two patients sustained a grade 2 pedicle screws breach in the lumbar spine in a patient who sustained no neurological deficit (e.G., no new deficit or csf leak).However, one patient with a complicated grade 2 internal breach following the placement of two cervical pedicle screws (e.G., confirmed utilizing postoperative ct) [figure 2a and b] compromising the c5 and c7 roots, respectively, developed the new onset of right upper extremity weakness [figure 2a-d].The patient required revision of these pedicle screws with o-arm 3d navigation [figure 2e and f], and her deficit improved (e.G., from preoperative grade 2 to postoperative grade 3 at 4 weeks and grade 4 at 4 months).

• 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5696143
• MDR Text Key: 46465325
• Report Number: 1723170-2016-01041
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR