N/A 960-717 (UDI 00673978090498)Recalls & reported problems
Medtronic Navigation, Inc. · INST 960-717 ADJ DRILL STOP 3.2MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00673978090498), received between Apr 13, 2017 and Apr 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Imprecision” (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
- Imprecision1
Patient problems
- Injury1
- 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.
InjuryApr 13, 2017Imprecision; Imprecision
A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT ON (B)(6) 2017, ALLEGING THAT ON (B)(6) 2017, WHILE IN A SPINE PROCEDURE, THE SITE'S UNIVERSAL DRILL GUIDE (UDG) DRILL STOP WAS NOT FUNCTIONING PROPERLY, AND THE DRILL WENT DEEPER THAN EXPECTED. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: Injury; No Consequences Or Impact To Patient
MAUDE report 6491850 ↗
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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 13, 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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