MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2025
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 a straight thoracic pedicle probe abruptly snapped while it was being removed from the left side of the s1 pedicle.A fragment of the broken probe was retained inside the patient, and there was concern regarding the integrity of the probe.The surgeon decided to leave the retained fragment in the patient, considering it the safer option.This issue caused less than 1 hour surgical delay.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3, h6: multiple fdd/annex a codes were reported.A040103 was coded for probe abruptly snapped while it was being removed from the left side.A23 was coded for fragment of the broken probe was retained inside the patient.No products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H2: please see section d9 for when the device was available for analysis.H2-h6: the probe was returned to the manufacturer for analysis.Through visual and physical examinations, it was revealed that the tip of the returned probe had been severely twisted and broken off at the tip.There were also impact marks at the back end.A physical damage failure mode was identified.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.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: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22978508
• Report Number: 1723170-2025-03145
• Device Sequence Number: 9370396
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: (01)00763000054205(11)210829(10)210829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 210829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/22/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 107 KG