MAUDE Adverse Event Report: NDI (NORTHERN DIGITAL INC.) NDI PASSIVE SPHERES; N/A

Model Number	8801075
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient consequences were not reported with the initial report.
Event or Problem Description
(b)(6) 2023 (b)(6) (rep hcp for): medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that when an attempt was made to close the surgical incision, the grey portion of the navigation sphere came off in the dome and remained in the operative field.When the instrument was checked the navigator sphere was found with the half grey portion missing.The device was found and did not remain in the patient's body.

• Brand Name: NDI PASSIVE SPHERES
• Common Device Name: N/A
• Manufacturer (Section D): NDI (NORTHERN DIGITAL INC.); 103 randall drive; waterloo, ontario N2V 1 C5; CA N2V 1C5
• Manufacturer (Section G): TEAM TECH INC; brecha e-99 nte., industrial; reynosa secc norte, 88788; reynosa, tamaulipas ; MX
• Manufacturer Contact: michael stocks ; 103 randall drive; waterloo, ontario N2V 1-C5 ; CA N2V 1C5
• MDR Report Key: 22979769
• Report Number: 3002743211-2025-00066
• Device Sequence Number: 9540805
• Product Code: HAW
• UDI-Device Identifier: 00805832070036
• UDI-Public: 010080583207003617250328
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: 8801075
• Device Catalogue Number: 8801075
• Device Lot Number: 2304101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2020
• 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