EXPEDIUM SFX 289410400Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM SFX CROSS CONNECTOR SYSTEM STABILIZER · Class 1
All models of EXPEDIUM SFX (14)
Data updated Oct 18, 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 10705034224466), received between Apr 12, 2024 and Apr 16, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Twisted/Bent3
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.
MalfunctionApr 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DETERMINED THE DEVICES WERE WORN OUT DUE TO WEAR AND TEAR OR WERE BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SFX STABILIZER FOR (B)(4). COMPLIANT IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19118122 ↗MalfunctionApr 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DETERMINED THE DEVICES WERE WORN OUT DUE TO WEAR AND TEAR OR WERE BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SFX STABILIZER FOR (B)(4). COMPLIANT IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117938 ↗MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX STABILIZER. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101536 ↗
Other CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY devices
- EXPEDIUM 279712580Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY69 reports
- AESCULAP MD610Aesculap, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- 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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