MAUDE Adverse Event Report: NORTHERN DIGITAL INC.(NDI) NDI PASSIVE SPHERES

Model Number	8800738
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Initial report: on april 08, 2025, ndi's sphere distributor, amplitude, received a complaint from (b)(6) hospital in france, alleging that ndi's sensors (spheres) returned a strobe-like image to their tracking system, thereby making it impossible to validate the various navigation phases.Due to this issue, the surgical team determined that it was impossible to progress through the various operating stages of the planned surgery.This resulted in a 35 minute delay in the surgery.The surgical team was able to resolve the issue by using sensors from another company.It was reported that there was no negative impact on patient outcome.
Additional Manufacturer Narrative
Ndi will complete a follow-up report as soon as additional information becomes available.

• Brand Name: NDI PASSIVE SPHERES
• Common Device Name: NDI PASSIVE SPHERES
• Manufacturer (Section D): NORTHERN DIGITAL INC.(NDI); 103 randall drive; waterloo, ontario, canada N2V 1 C5; CA N2V 1C5
• Manufacturer (Section G): TEAM TECHNOLOGOES; av mike allen 1220; industrial reynosa, 88780; reynosa, tamps ; MX
• Manufacturer Contact: michael stocks ; 103 randall drive; waterloo, ontario, canada N2V 1-C5 ; CA N2V 1C5
• MDR Report Key: 22095203
• Report Number: 3002743211-2025-00001
• Device Sequence Number: 20564415
• Product Code: HAW
• UDI-Device Identifier: 20805832040026
• UDI-Public: 012080583204002617290910
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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 Model Number: 8800738
• Device Catalogue Number: 8800738
• Device Lot Number: 2409601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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