N/A 960-717 (UDI 00763000055394)Recalls & reported problems
Medtronic Navigation, Inc. · INST 960-717 ADJ DRILL STOP 3.2MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000055394), received between Dec 6, 2018 and Dec 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Image Display Error/Artifact; Image Display Error/Artifact
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE DRILL STOP DID NOT LOCK PROPERLY. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846281 ↗MalfunctionDec 6, 2018Output Problem; Output Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A UNIVERSAL DRILL GUIDE DRILL STOP BEING USED WITH A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE VERIFY INSTRUMENTS TASK OF A CERVICAL SPINE PROCEDURE, THE DRILL STOP WAS INCREDIBLY HARD TO MOVE UP AND DOWN TO LOCK AND UNLOCK AND WHEN THE DRILL BIT WAS IN THE DRILL STOP IT WAS INCREDIBLY LOOSE AND KEPT FALLING. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8137512 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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