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	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon placed four screws utilizing the xvision system.During confirmation of the instrumentation process, it was determined by the surgeon that the left l2 pedicle screw, which was positioned second, was misplaced (low on the pedicle).The surgeon opted to redirect the screw utilizing navigation, however, subsequent scans were not able to be registered.Thus, the surgeon redirected the screw using traditional percutaneous freehand techniques.Upon reviewing all system logs and clinical data, it was determined that the most likely contributing factor in the misplaced left l2 pedicle screw, is a deviation of the tool at the entry point - commonly described as tool skiving.Tool skiving occurs when the entry point topography and planned trajectory angulation do not intersect at a perendicular angle (90o in relation to one another).The investigation concluded that the event occurred due to the tool skiving, which is probably also affected by the patient's anatomy.There was no indication of a system (hardware/software) malfunction.

• 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: 16020928
• Report Number: 3016571711-2022-00013
• Device Sequence Number: 15193708
• 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): 11/30/2022

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: 11/01/2022
• Initial Report FDA Received Date: 12/21/2022
• 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