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

Model Number 9733858

Device Problem Imprecision (1307)

Patient Problem Pain (1994)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Restelli, u., anania, c.D., porazzi, e., banfi, g., croce, d., fornari, m., costa, f.An observational analysis of costs and effectiveness of an intraoperative compared with a preoperative image-guided system in spine surgery fixation: analysis of 10 years of experience.Journal of neurosurgical sciences.2022.66(350-5) doi: 10.23736/s0390-5616.19.04638-1 background: image-guided navigation systems are well established technologies; their use in clinical practice is constantly growing.To date many publications have demonstrated their accuracy and safety.However, the acquisition and maintenance costs are high.In an era in which health expenditures are rising exponentially, analyses of the economic impact of new technologies are mandatory to assess their sustainability.Methods: this is a retrospective analysis to assess the overall costs of a series of patients admitted to our department of neurosurgery for spinal instrumentation.We compared two different types of spinal navigation systems: based on preoperative ct scan (january 2003-april 2009) and on intraoperative ct-like scan (april 2009-march 2013).We used a micro-costing approach by a hospital perspective considering all the phases of the treatment process, from preadmission testing to discharge.Results: the study includes 875 patients.Baseline data, hospitalization and complications were similar for both.Mean cost was ¿ 7305.9 for intraoperative ct scanprocedure and ¿ 7666.2 for preoperative image-guided system.The effectiveness, in terms of screw accuracy was similar.Higher costs were related to implanted materials, human resources, and disposable.Conclusions: there was a statistically significant difference between the two groups in terms of costs.A break-even point for the acquisition of an intraoperative image system is calculated in almost 130 procedures.Moreover, nowadays this system is used for more than only screw insertion reducing the financial impact of this technology on a hospital.Reported events: one patient underwent revision surgery for screw malposition causing nerve root compression.

• Brand Name: STEALTHSTATION® S7¿
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16014688
• MDR Text Key: 305812982
• Report Number: 1723170-2022-02100
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 63 YR
• Patient Sex: Male