EXPEDIUM VERSE 199723630SRecalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 x 30mm · Class 2 · Implant
All models of EXPEDIUM VERSE (90)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034443478), received between Feb 18, 2022 and Feb 18, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A REVISION OF STABILIZATION WITH EXPLANTATION OF THE VERSE SYSTEM AND THE PLIVOS CAGE. THE SUBSEQUENT REIMPLANTATION OF SOLERA MEDTRONIC SCREWS OF LARGER DIAMETER AND IMPLANTATION OF THE T PAL CAGE OCCURRED. THE STEM OF THE SCREWS WERE POSITIONED ON LEVEL S1 AND IMPLANTED IN A PREVIOUS OPERATION ON THE SAME PATIENT IN ANOTHER HOSPITAL WAS BROKEN. THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 6.0X30. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13562096 ↗InjuryFeb 18, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A REVISION OF STABILIZATION WITH EXPLANTATION OF THE VERSE SYSTEM AND THE PLIVOS CAGE. THE SUBSEQUENT REIMPLANTATION OF SOLERA MEDTRONIC SCREWS OF LARGER DIAMETER AND IMPLANTATION OF THE T PAL CAGE OCCURRED. THE STEM OF THE SCREWS WERE POSITIONED ON LEVEL S1 AND IMPLANTED IN A PREVIOUS OPERATION ON THE SAME PATIENT IN ANOTHER HOSPITAL WAS BROKEN. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X30. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13562093 ↗
Other Thoracolumbosacral pedicle screw system 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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