MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; Orthopedic stereotaxic instrument

Model Number	10-0001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary spinal fusion surgery took place on (b)(6)2024.The surgeon registered to l4 and l5 and accepted registration verification and proceeded to navigate.Four screws were placed with 7d navigation with no concerns throughout navigation.From intra-operative x-rays taken during the procedure after final rod placement, it was noted that the left l5 screw had breached the superior endplate and entered the disc space.The surgeon then decided to complete the surgery and schedule a revision procedure two days later.7d surgical was notified that the revision surgery was complete on (b)(6)2024.On (b)(6)2024, 7d surgical was notified that the patient is stable and in good condition, as reported by this physician.
Additional Manufacturer Narrative
The results of the software log analysis determined that the system and software performed in accordance with system and software design and performance specifications.Review of the software log shows that during registration verification, registration accuracy was not verified at l5 prior to accepting the registration and proceeding to navigate, not in accordance with the instructions for use.

• Brand Name: 7D SURGICAL SYSTEM
• Common Device Name: Orthopedic stereotaxic instrument
• 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: 19823171
• Report Number: 3012098629-2024-00001
• Device Sequence Number: 15624404
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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