EXPEDIUM 286250000Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR DISTRACTOR · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034211541), received between Jul 10, 2024 and Nov 6, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device-Device Incompatibility2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23491749 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23491721 ↗MalfunctionJul 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE DEVICE MALFUNCTIONED INTRAOPERATIVELY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A TRADITIONAL DISTRACTOR WHICH MADE THE PROCEDURE LONGER. A SURGICAL DELAY OF 10 MINUTES WAS NOTED. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609241 ↗MalfunctionJul 10, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TANDEM RETRACTOR BENT IN THE PATIENT DURING A ROD LENGTHENING. IT WAS PART OF THE EXPEDIUM BASIC ROD LENGTHENING. THE TIP OF THE INSTRUMENT THAT INSERTS TO THE CONNECTOR OF THE ROD BENT. SECOND INSTRUMENT AVAILABLE IN THE SET WAS USED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXT TANDEM CONN DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19715642 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.