N/A 963-791Recalls & reported problems
Medtronic Navigation, Inc. · INST 963-791 PERCUTANEOUS CLAMP LONG · 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 00681490523981), received between Mar 6, 2017 and Mar 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2017Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE PERCUTANEOUS CLAMP WOULD NOT TIGHTEN ANYMORE. THE REPORTED ISSUE OCCURRED DURING NAVIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6380020 ↗
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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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