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

Model Number	10-0001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As per reporter, surgeon was navigating an l5-s1 fusion with two iliac bolts.It was discovered that both bolts in the right side were in soft tissue.Navigation was abandoned and surgical procedure proceeded with fluoro.No patient harm was noted.
Additional Manufacturer Narrative
Event log review could not establish a definitive root cause.Quality compliance will continue to monitor similar complaints as part of routine post-market surveillance.
Additional Manufacturer Narrative
Complaint review on 01/14/2026 noted that the root cause is identified.This report provides correction to previously submitted h11 manufacturer's narrative: engineering log review identified that the surgeon picked points on the l5-s1 level; however, accuracy was checked on the pelvis.A simulated accuracy check on l5-s1 mirrored the trajectory observed in fluoro.

• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 22923904
• Report Number: 3012098629-2025-00020
• Device Sequence Number: 9162122
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: Other
• Patient Sex: Unknown