MAUDE Adverse Event Report: AUGMEDICS LTD. 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	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A thoraco-lumbar open surgery was planned on t10-l4.2 screwdrivers were calibrated to be used during the case (t1 and t4).Investigation revealed difficulties in the calibration and verification of both screwdrivers that were used for placing the 14 screws.Only one of the instrumented screws was found to be high compared to the expected trajectory (rl4).A confirmation scan showed right l4 screw was high in the pedicle, and the surgeon felt had a different trajectory than shown on navigation.The surgeon opted to redirect with navigation.After redirecting and confirmation scan the screw was still high and the surgeon opted to freehand screw.In this case, the user used depuy expedium screws.If the sleeve is not perfectly aligned, the screw isn't firmly fixated, thus the screw while fixated to the screwdriver is identified as bent by the xvision sw, leading to a failure in verification.The investigation concluded that the main cause of inaccuracy was the screw skiving.Additionally, it may be that the tulip head wasn't completely fixated during the insertion, leading to a discrepancy between the displayed virtual screw trajectory and the actual pedicle.Better clarification regarding careful loading of the screw in this type of screwdriver and screws may be required.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: XVISION SPINE SYSTEM (XVS)
• Manufacturer (Section D): AUGMEDICS LTD.; 2 ha-otsma st.; p.o.b 345; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): AUGMEDICS LTD.; 2 ha-otsma st.; p.o.b 345; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: shay ramon ; 2 ha-otsma st.; p.o.b 345; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 16734659
• Report Number: 3016571711-2023-00001
• Device Sequence Number: 6862699
• Product Code: OLO
• UDI-Device Identifier: 07290113780231
• UDI-Public: 07290113780231
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 03/13/2023

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: 03/14/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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