EXPEDIUM SFX 189403211Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR F11 6.35 x 41mm · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034168852), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
1 other recall cover devices cleared under the same FDA submission (K062196, K111136); 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON (B)(6) 2024 HER PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22194703 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062196, K111136. 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, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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