CORUS Navigation Access System DX-01-160Recalls & reported problems
Providence Medical Technology, Inc. · The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation. · 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 00852776006638), received between Dec 11, 2025 and Dec 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionDec 11, 2025Break
(B)(6)-LX DISPOSABLE BROKE DURING USE. ALL PIECES WERE SEQUESTERED. ALL PIECES WERE PRESENT AND ACCOUNTED FOR. NOT AN IMPLANT BUT A DISPOSABLE ITEM NEEDED TO COMPLETE PROCEDURE. A SECOND UNIT WAS OPENED TO COMPLETE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777703 ↗
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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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