MAUDE Adverse Event Report: AUGMEDICS LTD. XVISION SPINE SYSTEM (XVS)

Model Number	SWIVEL 5-6 MM UNIVERSAL TOOL ADAPTER LEG UP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was using a burr to navigate and burr his starting points for facetectomies when the button on the adapter popped out of the adapter.Upon taking ap fluoro images the surgeon noticed a small spring that must have belonged to the adapter in the imaging and took it out of the patient.The adapter was removed from the tray and sent out for further investigation.The investigation concluded that a malfunction of the adapter had occurred.It is important to clarify that in this situation where the spring could have been left in the patient's body, it could theoretically result in an un-desire tissue response.The risk in a tissue response has been analyzed and was found to be nonhazardous to the patient's health over time.Since a device malfunction has occurred, 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: 17997291
• Report Number: 3016571711-2023-00013
• Device Sequence Number: 20521509
• 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): 10/24/2023

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: SWIVEL 5-6 MM UNIVERSAL TOOL ADAPTER LEG UP
• Device Catalogue Number: AMCRMU05
• 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: 09/26/2023
• Initial Report FDA Received Date: 10/24/2023
• 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