EXPEDIUM 179732650Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 x 6 x 50mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034073880), received between Aug 2, 2022 and Aug 2, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2022, THE SPECIALIST NOTED THAT THE DEVICES IN QUESTION WERE EXPERIENCING EXPULSION OF THEIR INNER CORES. THE SURGERY WAS COMPLETED USING OTHER DEVICES, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 6 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153041 ↗MalfunctionAug 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2022, THE SPECIALIST NOTED THAT THE DEVICES IN QUESTION WERE EXPERIENCING EXPULSION OF THEIR INNER CORES. THE SURGERY WAS COMPLETED USING OTHER DEVICES, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 6 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15152928 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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