MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7® NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734685
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Akgun, m.Y., manici, m., ates, o., gokdemir, m., gunerbuyuk, c., tepebasili, m.A., baran, o., akgul, t., oktenoglu, t., sasani, m., ozer, a.F.Unlocking precision in spinal surgery: evaluating the impact of neuronavigation systems.Diagnostics.2024.14 (1712).Https://doi.Org/10.3390/diagnostics14161712 abstract: objective: in spine surgery, ensuring the safety of vital structures is crucial, and various instruments contribute to the surgeon¿s confidence.This study aims to present outcomes from spinal cases operated on using the freehand technique and neuronavigation with an o-arm in our clinic.Additionally, we investigate the impact of surgical experience on outcomes by comparing early and late cases operated on with neuronavigation.Method: we conducted a retrospective analysis of spinal patients operated on with the freehand technique and neuronavigation in our clinic between 2019 and 2020, with a minimum follow-up of 2 years.Cases operated on with neuronavigation using the o-arm were categorized into early and late groups.Results: this study included 193 patients, with 110 undergoing the freehand technique and 83 operated on utilizing o-arm navigation.The first 40 cases with neuronavigation formed the early group, and the subsequent 43 cases comprised the late group.The mean clinical follow-up was 29.7 months.In the o-arm/navigation group, 796 (99%) of 805 pedicle screws were in an acceptable position, while the freehand group had 999 (89.5%) of 1117 pedicle screws without damage.This rate was 98% in the early neuronavigation group and 99.5% in the late neuronavigation group.Conclusions: the use of o-arm/navigation facilitates overcoming anatomical difficulties, leading to significant reductions in screw malposition and complication rates.Furthermore, increased experience correlates with decreased surgical failure rates.Reported events: a total of eight screws had complications, including six with lateral penetration (4-iia, 2-iiia) and two with medial penetration (1-iib, 1-iiib), all detected and revised perioperatively.Superficial wound infection observed in two patient additional information was received.It was reported that no medtronic products were involved with the adverse events.See attached literature article.
Additional Manufacturer Narrative
A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.H3,h6) no parts have been received by the manufacturer for evaluation.This event was initially reported in regulatory rep #: 1723170-2024-03201.This new report is being submitted to capture system (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STEALTHSTATION® S7® NAVIGATION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20694454
• Report Number: 1723170-2024-03574
• Device Sequence Number: 6489269
• Product Code: HAW
• UDI-Device Identifier: 00643169505827
• UDI-Public: 00643169505827
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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?: No
• Device Model Number: 9734685
• Device Catalogue Number: 9734685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male