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

Model Number	10-0001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dural Tear (1417); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/19/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
No definitive root cause could be identified for the disc space breach at c3-c6.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
On 19 feb 2026, orthofix was made aware of the following event that occurred during surgery using 7d surgical flash imaging.Per the reporter, the surgeon had difficulty achieving an accurate navigation registration.During this time, a dural tear occurred and blood loss was observed.As per reporter, a spinous process clamp was used as a reference frame, and the surgeon elected to place screws using freehand technique.Information reported indicated the procedure progressed to the thoracic spine where the preoperative plan was to place pedicle screws at t1-t2.During surgery, navigation registration was archived with anatomical points corresponding to t2 and t3, and intraoperative imaging confirmed that the screws were placed at t2-t3 and were not revised.Screws were navigated at c3-c6.Intraoperative imaging identified screws placed in the disc space.The left-sided screws were revised.The right-sided screws were assessed by the surgeon as acceptable.
Additional Manufacturer Narrative
Multiple attempts have been made to try and retrieve further event information with no successful response.Should new information become available a supplemental report will be submitted.

• 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: 24654496
• Report Number: 3012098629-2026-00002
• Device Sequence Number: 12178696
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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: Death
• Patient Sex: Unknown