N/A 9734907 (UDI 00763000210632)Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER KIT 9734907 NAVLOCK UNIV ORANGE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000210632), received between Aug 5, 2019 and Mar 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ORANGE INSTRUMENT TRACKER WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21509569 ↗MalfunctionJan 14, 2025Use of Device Problem; Use of Device Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DRIVER AND TRACKER WERE DEFECTIVE. THE DRIVER WAS BROKEN OFF AND THE TRACKER DIDN'T HOLD ONTO THE OTHER INFORMATION DUE TO THE RETAINING CLIP BEING BROKEN OFF. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21150441 ↗MalfunctionAug 5, 2019Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE SITE HAD A DEFECTIVE ORANGE TRACKER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8862352 ↗
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- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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