MAUDE Adverse Event Report: AUGMEDICS INC. XVISION SPINE SYSTEM (XVS)

Model Number	ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In an mis procedure, a tall clamp was placed on the sp of t7, and its stability was confirmed.Upon incision, an initial landmark check confirmed anatomy with tactile feedback from the surgeon, and the screws were instrumented bilaterally on t7 and t6.A landmark check was performed at t5, and the surgeon noted that tactile feedback was not correlating with the nav image screen.Ap and lateral images of screws instrumented showed that screws were placed high and not in the pedicle like on the nav images.Surgeon elected not to re-spin and the screws were revised under c-arm fluoro, as well as the rest of the construct.A thorough analysis was conducted and showed the virtual trajectories presented by the xvs system appear high but not in the disk space as the screws.Hence, there seems to be a discrepancy between virtual and actual placement.Two issues were found as possible causes for the discrepancy between the reported deviated screws and the incorrect navigation indication: 1.Movement of x-marker position in relation to patient marker during registration, due to "breaking breathing." 2.Movement of clamp during instrumentation due to bumping into the clamp none of the findings indicate a malfunction of the system.Since this event resulted in screws redirection, which is considered a serious injury, it was decided that this event needs to be reported.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: XVISION SPINE SYSTEM (XVS)
• Manufacturer (Section D): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer (Section G): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer Contact: shay ramon ; 2 ha-otsma st.; p.o.b 345; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 17446953
• Report Number: 3016571711-2023-00008
• Device Sequence Number: 7270163
• Product Code: OLO
• UDI-Device Identifier: 07290113780231
• UDI-Public: 07290113780231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211188
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE
• Device Catalogue Number: ACC00008
• 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: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (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