EXPEDIUM VERSE 199723540Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 x 40mm · Class 2 · Implant
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 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 10705034403267), received between Jan 11, 2022 and Jan 11, 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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NOTICED IN A POST-SURGERY MRI, THAT TWO EXPEDIUM VERSE ADVANCED SCREWS WERE BROKEN IN THE TIP. THE TIP IS LOCATED INSIDE THE VERTEBRAL BODY. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED. ONE SCREW (BUT NOT THE TIP) WAS REMOVED AND ANOTHER TWO SCREWS WERE PLACED TO RESTORE THE STABILITY OF THE IMPLANT. THE SECOND SCREW REMAINED IMPLANTED, AND SHOULD NOT CAUSE PROBLEM TO THE STABILITY OF THE IMPLANT. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13230445 ↗InjuryJan 11, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NOTICED IN A POST-SURGERY MRI, THAT TWO EXPEDIUM VERSE ADVANCED SCREWS WERE BROKEN IN THE TIP. THE TIP IS LOCATED INSIDE THE VERTEBRAL BODY. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED. ONE SCREW (BUT NOT THE TIP) WAS REMOVED AND ANOTHER TWO SCREWS WERE PLACED TO RESTORE THE STABILITY OF THE IMPLANT. THE SECOND SCREW REMAINED IMPLANTED, AND SHOULD NOT CAUSE PROBLEM TO THE STABILITY OF THE IMPLANT. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient
MAUDE report 13229883 ↗
Other bone cement, posterior screw augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723655Medos International Sàrl · bone cement, posterior screw augmentation4 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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