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	Insufficient Information (4580)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event logs were reviewed, and it was noted that not enough of the vertebral body was visible in the flash for the system to make a good registration.The following warning was displayed on the interface: "attention: registration accuracy may not be suitable for navigation." the surgeon accepted the registration as is and proceeded with navigation.The root cause is user error; the surgeon did not heed the warning prompt displayed by the system.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
On (b)(6) 2025, orthofix was made aware of the following event during navigation using 7d surgical flash imaging.Per the reporter, the surgeon performed a segmental registration on l4 then proceeded to use the ball tip pointer, navigated burr, and navigated tap to make pilot holes.A 3d c-arm spin was performed, and it was noted that the right l4 and l5 pilot holes were not accurate and appeared to go through the foramen.Neuro-monitoring did not report any issues.The surgery was completed without navigation.It was reported by the pa that the screws were placed in the same trajectory as the original navigated pilot hoes.Patient condition was not reported.

• 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
• MDR Report Key: 24089578
• Report Number: 3012098629-2026-00001
• Device Sequence Number: 5905244
• 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
• Report Date (Section B): 01/15/2026

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: 12/23/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• 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: Other
• Patient Sex: Unknown