Navigated Infinity ™ Instruments NAV3606195Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREWDRIVER NAV3606195 NAVIGATD THREADED · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169725461), received between Feb 12, 2025 and Nov 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Material Deformation1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Break; Material Deformation; Break; Material Deformation
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER HAD DAMAGE TO THE THREADED END AND A THREAD BROKE OFF. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS USED NUMEROUS TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578832 ↗MalfunctionFeb 23, 2025Break; Mechanics Altered; Break; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS PLACING A PEDICLE SCREW. DURING INSERTION THE DRIVER'S THREAD BROKE, AND IT COULD NO LONGER ENGAGE THE SCREW. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PROCEDURE: CERVICAL FUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442168 ↗MalfunctionFeb 12, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION FOR UNKNOWN INDICATION. IT WAS REPORTED THAT SURGEON WAS USING THE DRIVER WITH A SCREW TO PLACE A TRANSARTICULAR SCREW, CERVICAL, C1-C2. THREAD ON SCREWDRIVER BROKE, AND IT COULD NO LONGER PROPERLY THREAD IN AND ENGAGE THE PEDICLE SCREW. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362478 ↗
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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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