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

Model Number	NAVIGATED TOOL ADAPTOR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgery: removal of hardware l2-l5, new screws placed with xvision from t9-s1.During instrumentation, a navlock tool adaptor was detached from the gearshift tool that was fixated on it.Visual inspection of the adapter revealed that the adapter was damaged.A new adapter was placed onto the gearshift tool and the procedure was completed with no further issues.Post-operatively, one of the stainless-steel balls of the adapters was found in a sterile area, near the other tools.An o-arm spin and flat panel x-ray were performed, and the surgeon and team did not see any other balls within the patient's body.As a result, all site navlock adaptors were inspected, and 8 were found damaged with missing one, or two, balls and broken peek.The adapters are manufactured from well-known used materials in medical devices.All 9 damaged adapters were quarantined at the site.Four additional adaptors at the site were found to be undamaged.The company tried to reproduce the event using similar tools and adaptors following a similar clinical workflow of the surgeon with no success.A malfunction during the manufacturing process was also ruled out, as well as a damaged batch.All other adapters were visually inspected at all other sites and found to be undamaged.While the investigation is continuing, at this point it increasingly appears that this event is isolated to the (b)(6) hospital.According to 21 cfr 803, mdr is not required since malfunction was assessed not to cause a serious injury.Yet, the company decided to report this event.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: XVISION SPINE SYSTEM (XVS)
• Manufacturer (Section D): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer (Section G): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer Contact: shay ramon ; 2 ha-otsma st.; p.o.b 345; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 17379384
• Report Number: 3016571711-2023-00006
• Device Sequence Number: 6083817
• Product Code: OLO
• UDI-Device Identifier: 07290113780231
• UDI-Public: 07290113780231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/24/2023

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: NAVIGATED TOOL ADAPTOR
• Device Catalogue Number: AMC04180
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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