MAUDE Adverse Event Report: CAPTIVA SPINE WATCHTOWER ROAM SPINE NAVIGATION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	SYS-NAVI02
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Captiva spine received ffr 568 on (b)(6) 2025 for watchtower roam navigation system, model sys-navi02, serial (b)(6), used during olif/tlif l4-s1.Navigation discrepancy was observed when the displayed t-awl position did not match confirmatory fluoroscopy.The surgeon discontinued navigation and completed the procedure with fluoroscopy.No patient harm occurred.Dhr review found no nonconformities; c-arm movement during ap image capture was identified as the primary likely contributing factor.This report is being submitted beyond the initial reporting timeframe because additional investigation and review were required to assess the event, obtain and evaluate supporting information, complete the health hazard evaluation, and finalize the manufacturer's reportability determination.
Event or Problem Description
On (b)(6) 2025, a field feedback report (ffr) was received from company representative (b)(6) of (b)(4).During the case, the surgeon initiated screw placement at l5 using fluoroscopy due to navigation system registration delays.Navigation was then started at l5 on the right, resulting in accurate screw placement.However, when proceeding to the right l3, the registration was noted to be inaccurate.While the system displayed the t-awl location as correct, a confirmation x-ray revealed the awl to be approximately 1 cm inferior to the watchtower display.The axial trajectory appeared accurate, and the surgeon compensated by repositioning the awl superiorly until alignment was confirmed radiographically.The watchtower image then showed the awl to be 1 cm superior to the pedicle.Following this discrepancy, the surgeon discontinued navigation and completed the procedure using standard x-ray guidance.No patient harm was reported on this event, but as the root cause of the inaccurate instrument placement could not be conclusively determined at the time of the procedure, it was decided to report this case.All screws were ultimately positioned correctly using fluoroscopy without any adverse events.

• Brand Name: WATCHTOWER ROAM SPINE NAVIGATION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): CAPTIVA SPINE; 967 n alternate a1a; ste 1; jupiter 33477
• Manufacturer (Section G): REMEX MEDICAL; 4f., no.9, jingke road.,; nantun dist.; taichung city, taiwan 40852 ; TW 40852
• Manufacturer Contact: delmer romero ; 967 n alternate a1a, suite 4; jupiter, FL 33477 ; 5612779480
• MDR Report Key: 24649308
• Report Number: 3006082533-2025-00001
• Device Sequence Number: 18644126
• Product Code: OLO
• UDI-Device Identifier: 04719894320984
• UDI-Public: 04719894320984
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: SYS-NAVI02
• Device Lot Number: 2502130010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown