MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; STEREOTAXIC SURGERY SYSTEM

Model Number	10-0001
Medical Device Problem Codes	Calibration Problem (2890); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the session logs, it appears that the main issue of inaccuracy was a poor calibration of the flashlock used on the screwdriver.When placing the right c2 screw, the final positioning of the flashlock looks significantly farther superior to the orientation of the ball tip probe on the sagittal view (seen here as a saved trajectory).On the left side, the divergence is seen again, but less significantly.If the true position of the instrument remains constant, it would make sense that the final screw position has breached the left c2 foramen.A review of dhr has been completed and the system did pass the performance tests during the initial build of the system.The root cause can most likely be attributed to a poor calibration of the flashlock used on the screwdriver.The root cause for this event is most likely be attributed to user error because of poor calibration of the flashlock used on the screwdriver.
Event or Problem Description
During navigation, surgeon registered c2 first and got minimal green on the left side.But surgeon did accuracy check and deemed it ok.Proceeded to drilled left c2 first and put a screw in using flashlock.Surgeon said the flashlock was off as the screw looked to be incorrectly placed and moved to the right-hand side.Drill and screw again using flashlock looked to be ok.Proceeded to move to c1 and re-registered.Surgeon said drill (universal tracker) was inaccurate so we re-registered.Drill and flashlock the screw right side then left.We did an o-arm spin at the end of the case.Right c2 screw and both c1 screws all ok.Left c2 screw has reached the vertebral artery.The artery was breached.The surgeon decided to leave the screw in that position as removing it may have caused further damage and bleeding control issues.Patient status is being monitored initially as of (b)(6)2024 - patient status is fine.

• Brand Name: 7D SURGICAL SYSTEM
• Common Device Name: STEREOTAXIC SURGERY 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: leo justin ; 60 scarsdale road; unit 118; toronto, ontario M3B 2-R7 ; CA M3B 2R7
• MDR Report Key: 21315716
• Report Number: 3012098629-2025-00001
• Device Sequence Number: 8019969
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2024
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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