MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; NAVIGATION SYSTEM

Model Number	10-0001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue occurred during navigation using the 7d surgial flash imaging system.Review of system logs and surgical notes confirmed that the unilateral registration was impacted by inadequate visualization of critical anatomical landmarks, particularly at the l4 lamina and l5 facet.Point 2 was initially registered high, and the resulting screw trajectory led to misplacement into the disc space.The root cause appears to be a combination of user error and limitations in the flash image quality due to poor exposure and shadowed anatomy.The surgeon corrected the trajectory intraoperatively using fluoroscopy.Based on available information, this event has been attributed to procedural technique in conjunction with imaging limitations, rather than a device malfunction.Post-market surveillance will continue to monitor for similar reports.
Event or Problem Description
During spinal navigation using 7d surgical flash imaging, the surgeon performed a unilateral registration at l4.Point 2 was registered high, and although the accuracy check appeared acceptable at the time, the system did not capture the anatomy clearly due to poor exposure and shadowing in the flash image.As a result, a pedicle screw was inadvertently placed into the disc space.The error was identified intraoperatively, and the screw was repositioned using fluoroscopic guidance.The patient remained stable throughout the procedure and did not require further intervention.

• Brand Name: 7D SURGICAL SYSTEM
• Common Device Name: NAVIGATION SYSTEM
• Manufacturer (Section D): 7D SURGICAL ULC; 60 scarsdale road; unit 118; toronto, ontario M3B 2 R7; CA M3B 2R7
• Manufacturer (Section G): 7D SURGICAL ULC; 60 scarsdale road; unit 118; toronto, ontario M3B 2 R7; CA M3B 2R7
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, ca 92008 ; CA 92008
• MDR Report Key: 21988828
• Report Number: 3012098629-2025-00003
• Device Sequence Number: 8553204
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: 10-0001
• Device Catalogue Number: 10-0001
• 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: 04/09/2025
• Initial Report FDA Received Date: 05/08/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown