EXPEDIUM 279702600NRecalls & reported problems
Medos International Sàrl · UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM TAP, DUAL LEAD 6mm · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034388366), received between Jul 15, 2021 and Dec 23, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut5
- Material Deformation5
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878227 ↗MalfunctionDec 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878218 ↗MalfunctionDec 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878192 ↗MalfunctionDec 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878190 ↗MalfunctionDec 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT PRODUCT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878178 ↗MalfunctionSep 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TAPS WERE DULL, UNABLE TO USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM TAP, DUAL LEAD 6MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207507 ↗MalfunctionSep 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TAPS WERE DULL, UNABLE TO USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM TAP, DUAL LEAD 6MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206284 ↗MalfunctionSep 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TAPS WERE DULL, UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20203072 ↗MalfunctionSep 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TAPS WERE DULL, UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202923 ↗MalfunctionSep 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TAPS WERE DULL, UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201592 ↗MalfunctionJul 15, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DOUBLE LEAD 6.0 TAP SHAFT SNAPPED. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 6MM DUAL-LEAD TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12174573 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.