EXPEDIUM 279763580Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM FLEXIBLE CLIP-ON REDUCTION SLEEVE FOR SI SET SCREWS 6.35 · Class 1
All models of EXPEDIUM (291)
Data updated Oct 18, 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 10705034200996), received between Jun 10, 2025 and Jun 10, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Mechanical Jam1
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.
MalfunctionJun 10, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE APPROXIMATOR SLEEVE WOULD NOT ADVANCE IN FLEX CLIP FOR SCOLIOSIS REDUCTION. TWO APPROXIMATOR SLEEVED FULLY JAMMED INTO FLEX CLIP. THREE APPROXIMATOR SLEEVES WOULD NOT ROTATE INTO FLEX CLIP. ON FURTHER INSPECTION - THE DISTAL TIP OF APPROXIMATOR SLEEVE X 3 WOULD NOT ROTATE. THE BEARINGS WERE COMPLETELY JAMMED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. OTHER APPROXIMATOR SLEEVES WERE USED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178008 ↗
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- ENDOPATH TT012Ethicon Endo-Surgery, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY47 reports
- NA 03.168.013Synthes GmbH · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY37 reports
- NA 214120Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Monoject 8881540111Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY19 reports
- MOSS 279712500Depuy Spine, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY12 reports
- Monoject 8881540133Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY10 reports
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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