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	Numbness (2415)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event logs were reviewed, and it was noted that the y-frame navigation reference was not fully captured during the initial spin.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.Navigation under a simulated adjusted registration displays the screw trajectories to be inferior of the pedicle as seen in fluoro.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
On 29 jul 2025, orthofix was made aware of the following event during navigation using 7d surgical flash imaging.Per the reporter, the surgeon navigated rs1 to rl2, cannulated via gearshift, and placed screws.On ls1 a discrepancy in accuracy was noticed.Fluoro imaging was performed, and it was discovered that the previous 6 screws were off either laterally, medially, or in the disc space.All screws were removed and navigation aborted.The patient is experiencing numbness in one leg and the opposite toe/foot.The surgeon noted that they both seem to be subsiding.

• 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: 22913418
• Report Number: 3012098629-2025-00008
• Device Sequence Number: 18358629
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: Required Intervention
• Patient Sex: Unknown