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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Perforation (2001); Iatrogenic Source (2498)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the article.Event date is approximated based on the article's accepted date.Therefore (b)(6) 2016 was used.Citation: daipayan guha, md, raphael jakubovic, msc, shaurya gupta, md et al.Spinal intraoperative three-dimensional navigation: correlation between clinical and absolute engineering accuracy.2017.The spine journal 1723170-2017-0; 2017, 489-498.Http://dx.Doi.Org/10.1016/j.Spinee.2016.10.020.Device serial number was estimated based on the site and study duration indicated on the article.Actual device information is unavailable.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 imaging and 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 attached article and forwarded it for evaluation for potential complaint reporting with intraoperative imaging system and navigation system.This study aimed to characterize the correlation between clinical pedicle screw accuracy, based on postoperative imaging, and absolute quantitative navigation accuracy.This is a retrospective review of a prospectively collected cohort.Thirty (30) patients undergoing first-time posterior cervical-thoraciclumbar-sacral instrumented fusion±decompression, guided by intraoperative three-dimensional computer-assisted navigation (can).All patients underwent posterior cervical-thoracic-lumbarsacral instrumented fusion with pedicle screw constructs, with or without decompression, for predominantly traumatic, degenerative, or neoplastic pathologies.Procedures were performed at (b)(6) health sciences centre by a single surgeon, with or without trainee assistance, from may 2014 to february 2015.Clinical or radiographic screw accuracy (heary and 2 mm classifications) and absolute quantitative navigation accuracy (translational and angular error in axial and sagittal planes).This research reviewed a prospectively collected series of 209 pedicle screws placed with can guidance.Each screw was graded clinically by multiple independent raters using the heary and 2 mm classifications.Clinical grades were dichotomized per convention.The absolute accuracy of each screw was quantified by the translational and angular error in each of the axial and sagittal planes.Acceptable screw accuracy was achieved for significantly fewer screws based on 2 mm grade versus heary grade (92.6% vs.95.1%, p=.036), particularly in the lumbar spine.Inter-rater agreement was good for the heary classification and moderate for the 2 mm grade.Radiographic classifications of pedicle screw accuracy vary in sensitivity across spinal levels, as well as in inter-rater reliability.Correlation between clinical screw grade and absolute navigation accuracy is poor, as surgeons appear to compensate for navigation registration error.Future studies of navigation accuracy should report absolute translational and angular errors.Clinical screw grades based on postoperative imaging may be more reliable if performed in multiple by radiologist raters.Of 209 screws, with 932 combined heary grades from five independent reviewers, 95.1% were rated as acceptable.On the 2-mm grading scale, from four independent reviewers assessing the same dataset, significantly fewer screws were rated as acceptable, at 92.6%.We theorized that the lack of observed correlation between clinical screw grade and absolute navigation accuracy may be due, in part, to surgeon compensation for perceived misalignment of virtual and anatomical intended screw entry points, based on surgeon visualization and knowledge of anatomical landmarks.For instance, a ¿perfect¿ entry point as shown by the navigation system, which is felt by the surgeon to be excessively lateral based on anatomical knowledge, may lead the surgeon to compensate by medializing their screw trajectory.In conclusion, the study stated that although can is a useful intraoperative adjunct, it cannot and should not replace dedicated subspecialty training, which affords the experience and anatomical knowledge required to identify and compensate for navigation errors.

• 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 ; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7082993
• MDR Text Key: 93731563
• Report Number: 1723170-2017-04566
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2017

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2011
• 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