N/A 9734907 (UDI 00763000057879)Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER KIT 9734907 NAVLOCK UNIV ORANGE · 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 00763000057879), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2018Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED PREOPERATIVELY WHILE VERIFYING INSTRUMENTS AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE ORANGE TRACKER WAS GETTING CAUGHT WHEN ATTACHED TO PROBES. A DIFFERENT TRACKER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660048 ↗
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- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- 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 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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