EXPEDIUM VERSE 199723840SRecalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 8.0 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
- 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 10705034444338), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.
Patient problems: Osteolysis
MAUDE report 23490960 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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