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

Model Number	9733857
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.The reported issue could not be confirmed or replicated, no components were replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a spinal procedure.During a procedure (l4-l5 fixation), after the initial image acquisition, a screw was inserted using both the navigation and a c-arm.  after inserting four screws, once screw was determined to be misaligned in the c-arm image.It was confirmed all four placed screws were misaligned with a confirmation image acquisition from the imaging system.After removing the four screws, they were reinserted.The patient's vitals and other conditions did not change.The reported issue resulted in a procedure delay of less than one hour.The procedure was completed with continued use of the imaging system.There was no patient involvement.After the procedure, the accuracy was checked with the imaging and navigation systems.No migration could be confirmed in a test scan using the bone model.After the event, the procedure was performed and the behavior was not reproduced.There was no problem with device accuracy.The patient's bone was reported to be hard and it was hit with a hammer when the screw was implanted and the reference was misaligned.It was possible the error occurred and the screw was misaligned.The cause was also shared with the surgeon.
Additional Manufacturer Narrative
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 or Problem Description
Additional information was received.The inaccuracy was not measured but believed to be around 6mm.The hospital staff accepted the rep's explanation that there might be a potential cause in the surgeon's procedure and further analysis was refused by them.
Additional Manufacturer Narrative
H3: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.H6: fdm b01, fdr c19, and fdc d15 are applicable to the software analysis.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.

• Brand Name: STEALTHSTATION® S7¿
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13501757
• Report Number: 1723170-2022-00176
• Device Sequence Number: 17131957
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 9733857
• Device Catalogue Number: 9733857
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 04/06/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/10/2022; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown