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	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After an xlink registration, the surgeon completed a landmark check with a probe and confirmed accuracy.The surgeon then brought in a burr and commented that it was not accurate.The burr was recalibrated, but the surgeon still felt that it was inaccurate.The surgeon proceeded with the left l4-5 screws and took fluoro shots.He was unhappy with screw placement and decided to re-spin and re-register using xlink.He confirmed the second registration and accuracy of the burr with landmark checks and repositioned the left l4-5 screws and then completed the right side.The redirected screws, using the xvs system and the same calibrated tools, were found to be positioned accurately, as confirmed with fluoro.The fact that re-spinning and re-registration, using the same calibrated tools, resulted in accurate screw positioning, suggests that there was a slight movement of either the patient marker or the patient after the first registration completion and instrumentation.None of the findings indicate a malfunction of the system.The investigation concluded that the event was solely the result of a user error, however, this error led to the repositioning of the screws, which considered as "serious injury".Therefore, it was decided to report this case.

• 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: 17787442
• Report Number: 3016571711-2023-00011
• Device Sequence Number: 6252887
• 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): 09/21/2023

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: 08/28/2023
• Initial Report FDA Received Date: 09/21/2023
• 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