WatchTower ROAM SYS-NAVI02Recalls & reported problems
Intai Technology Corp. · Spine Surgery Navigation System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04719894320984), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Failure to Align
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 A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649308 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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