MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NDI PASSIVE SPHERES; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	8801075
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that recognition was poor, making it difficult to pass verification.Additionally, the accuracy was low.It was noted that the inaccuracy was caused by all the instruments.A different passive marker was opened and used.There was no delay, and no reported patient impact.It was reported that the inaccuracy was "a few" millimeters.
Additional Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.G2: foreign country - japan h3, h6: multiple fdd/annex a codes were reported.A0908: applicable to the low accuracy.A0709: applicable to the poor recognition, and difficulty passing verification.The spheres were returned for analysis.When attached to a known good instrument and fully seated, 23 of the returned spheres displayed a good geometry error with normal tracking and verification.Two spheres had an uneven reflective surface, possibly from cleaning, and displayed a high geometry error.Three spheres were physically damaged with tool marks on both sides of the spheres, but still displayed a good geometry error.One sphere had lost the back side shell and was unusable.Codes b01, c07, and d02 are applicable to this analysis.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NDI PASSIVE SPHERES
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23441816
• Report Number: 1723170-2025-03615
• Device Sequence Number: 4695405
• Product Code: HAW
• UDI-Device Identifier: 20805832070030
• UDI-Public: (01)20805832070030(17)270108(10)2501201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8801075
• Device Catalogue Number: 8801075
• Device Lot Number: 2501201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown