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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon completed the procedure using alternative navigation and intraoperative o-arm imaging.The right l3 screw was repositioned, and the patient was reported to be in stable condition with no injury to surrounding anatomical structures.Based on the available information, including imaging review and procedural details, there is no indication of device malfunction.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
During navigation using 7d surgical flash imaging, the l2-3 segment was navigated off of l2 registration without issue.Navigation for l4 was subsequently performed using l3 registration.Intraoperative navigation images indicated that cannulations and screws were positioned within the pedicles.However, an o-arm spin performed at the end of the case revealed a lateral breach of the right l3 screw.The surgical team transitioned to an alternative navigation system and utilized intraoperative o-arm imaging to reposition the affected screw.The procedure proceeded without further complication.There was no patient injury; the breach did not contact or affect any vessels or neural structures.All screws were successfully repositioned, and the patient is reported to be doing well postoperatively.

• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 22116635
• Report Number: 3012098629-2025-00006
• Device Sequence Number: 11789618
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10-0001
• Device Catalogue Number: 10-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• 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: Other
• Patient Sex: Unknown