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	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This case was a revision case - l5-s1 bilateral screws were previously instrumented.L4 was instrumented using the xvs system.In an open procedure using a perc pin, the surgeon was noticed to bump into patient fixation before instrumentation.The rep notified the surgeon of the bump; however, the surgeon did not want to re-spin.The surgeon opted to conduct a thorough anatomy check at multiple landmarks instead, to verify the registration accuracy, and opted to continue with the navigation.L4 screws were found to be positioned inaccurately on ap/lateral x-ray images.L4 screws were removed and replaced accurately under fluoro.The patient is doing well.The investigation concluded that the main cause for the discrepancy between the xvs virtual display and actual screw placement, which led to inaccurate screw placement, is due to movement of the fixation point, which occurred due to the surgeon bumping into it.The surgeon did not follow the user manual instructions and evaluated the accuracy of only anatomical landmarks, percutaneously.A screw that is not positioned in the pedicle and that needed to be removed and replaced is considered according to the above definition as "serious injury".It is clear from the investigation that the event is solely the result of a user error or misuse, however, this error caused performance issues, as the system did not display the navigation information correctly.Additionally, the event caused a serious injury.If a user misused the device, and that results in a death or serious injury, this should 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: 17496261
• Report Number: 3016571711-2023-00010
• Device Sequence Number: 6354030
• 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): 07/13/2023

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: 07/13/2023
• Initial Report FDA Received Date: 08/10/2023
• 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