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

Model Number	10-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon completed the procedure using alternative navigation and intra-operative o-arm imaging.No patient injury was reported.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
On 09 may 2025, seaspine/orthofix was made aware of the following event during navigation using 7d surgical flash imaging.The first screw skived medially across sacral bridge when the sacral block registration was clamped onto s1.All other screws in block were accurate.The surgeon opted to suspend 7d navigation and switch to stealth/ o-arm to correct resulting in a delay of greater than 30 minutes.

• 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: 22160252
• Report Number: 3012098629-2025-00007
• Device Sequence Number: 15329900
• 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): 06/06/2025

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: 05/09/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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