EXPEDIUM SFX 189401102Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR F2 5.5 x 18mm · Class 2 · Implant
All models of EXPEDIUM SFX (14)
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 10705034167688), received between Dec 4, 2017 and Dec 4, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K062196, K111136, K142460); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2017Break; Break
ACCOUNT NAME: (B)(6) HOSPITAL. ON (B)(6) 2017, SURGERY FOR PELVIC FRACTURE WAS PERFORMED USING THE EXPEDIUM SAI AND SFX SYSTEM. THE FIXED AREA WAS S2 A1. THE FOLLOWING EVENTS WERE CONFIRMED DURING THE SURGERY. THE SURGEON ATTEMPTED A FINAL TIGHTENING AFTER COMPLETION OF SAI SCREW INSERTION AND ROD PLACEMENT. THEN, HE TRIED TO INSERT THE TRANSVERSAL CONNECTOR F2/18MM (PART#:189401102, LOT#: UNKNOWN) USING A SELF-RETAINING INSERTER, HOWEVER, THIS TRANSVERSAL CONNECTOR GOT STRIPPED AND BROKEN. FINALLY, HE REPLACED THIS TRANSVERSAL CONNECTOR WITH ANOTHER SIZE OF TRANSVERSAL CONNECTOR F1/16MM (PART#: 189401101, LOT#: UNKNOWN), AND INSERTION WAS SUCCESSFUL. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS COMPLETED WITHOUT ANY DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7080492 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062196, K111136, K142460. One submission often covers many models, so check the product and lot details in each record.
- Z-1674-2015 · Apr 21, 2015 · TerminatedEXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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