N/A 9736149Recalls & reported problems
Medtronic Navigation, Inc. · INTF KIT 9736149 ZEISS KINEVO · 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 00763000244774), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (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
- Device Sensing Problem1
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.
MalfunctionMay 6, 2026Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DID NOT RECOGNIZE ALL OF THE DOGBONE LIGHT EMITTING DIODES (LEDS) ON THE MICROSCOPE WHILE IT WAS DRAPED, OR UNDRAPED. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE (REP) RECONNECTED THE TRACKER MULTIPLE TIMES WITHOUT RESOLUTION. IT WAS REPORTED THAT THE BRACKET WAS UNDRAPED AND STILL WAS INTERMITTENTLY FLICKERING. IT SHOWED FLICKERING FROM THE FRONT OF THE TRACKER, BUT NOT FROM THE SIDES. THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE ISSUE OCCURRED INTRA-OPERATIVELY. THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A CRANIAL RESECTION PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089900 ↗
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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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