MAUDE Adverse Event Report: AUGMEDICS LTD XVISION SPINE SYSTEM (XVS); NAVIGATION SYSTEM WITH AUGMENTED REALITY

Model Number	AMCH00005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The movement of the clamp may cause for inaccurate registration and or display of tracking information, which may lead to serious injury.The dislocation of the clamp by muscle and fascia was evident, hence, the surgeon placed the clamp again and repeated the scan.It is suspected that the clamp was not closed as required.Augmedics' personnel reviewed the instructions and indications of complete clamp closure again with the surgeon.No patient harm.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: NAVIGATION SYSTEM WITH AUGMENTED REALITY
• Manufacturer (Section D): AUGMEDICS LTD; 1 ha-tsmikha st; yokneam illit, 20692 05; IS 2069205
• MDR Report Key: 10446962
• Report Number: 3016571711-2020-00002
• Device Sequence Number: 4044081
• Product Code: OLO
• UDI-Device Identifier: 07290113780002
• UDI-Public: (01)07290113780002(11)200402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: No Information
• Device Model Number: AMCH00005
• Device Catalogue Number: AMCH00005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other