EXPEDIUM VERSE 299704285Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN · Class 1
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034467405), received between Jun 15, 2023 and Apr 7, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility6
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Contamination /Decontamination Problem
THE ALIGNMENT GUIDE RETAINED A FRAGMENT OF THE FENESTRATED CANNULA AND SOME CEMENT INSIDE. NO FRAGMENTS REMAINED WITHIN THE PATIENT. THE SURGERY CONCLUDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800560 ↗MalfunctionMar 12, 2025Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT PREOPERATIVELY, THE CANNULA WAS CLOGGED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21584030 ↗MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CEMENT GOT STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136462 ↗MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CEMENT GOT STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN. THIS IS REPORT 2 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136459 ↗MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CEMENT GOT STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN. THIS IS REPORT 4 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136457 ↗MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CEMENT GOT STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN. THIS IS REPORT 5 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136455 ↗MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CEMENT GOT STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136454 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page