NA 3010-19-030Recalls & reported problems
Medos International Sàrl · NAVIGATION ENABLED INSTRUMENTS STANDARD THREAD TAP 4.0MM · 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 10705034561301), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
- Material Deformation1
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 16, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT IT WAS A POSTERIOR CERVICAL-THORACIC FUSION(C2-T2) FOR DROPPED HEAD SYNDROME. THE NAV TAP IS USED IN COMBINATION WITH THE ANTENNA FOR THE NAVLOCK NAVIGATION SYSTEM(MEDTRONIC). DURING THE SURGERY, THE SURGEON WAS UNABLE TO ASSEMBLE THE NAV TAP WITH THE PRODUCT OF THE MEDTRONIC. THIS WAS PROBABLY DUE TO A SLIGHT BEND IN THE SHAFT. OTHER TAPS OF DIFFERENT SIZES IN THE SAME SHIPPING SET WERE ABLE TO BE ASSEMBLED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817763 ↗
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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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