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EXPEDIUM VERSE 199723840Recalls & reported problems

Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 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
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 10705034402772), received between Oct 15, 2019 and Oct 15, 2019 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Tissue Damage2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EVENT: SCREWS WERE CHANGED AT LEVELS L2 AND S1, BECAUSE EXPEDIUM SCREWS WERE FENESTRATED, CONFIDENCE CEMENT WAS PLACED ON THE FENESTRATED SCREWS, AT THE TIME OF FINISHING PLACING THE CONFIDENCE CEMENT INSIDE THE SCREWS A CONTROL PLATE WAS TAKEN IN WHERE IT WAS NOTICED THAT THE CEMENT CAME OUT OF THE VERTEBRAL BODY THROUGH THE LOWER HOLE OF THE SCREW AT LEVEL S1. DIAGNOSIS: POST-OPERATED UNSTABLE LUMBAR COLUMN + SCREW EXTRUSION L2-S1 BILATERAL. SURGERY: CHANGE OF BILATERAL L2 AND S1 SCREWS WITH CANNULATED SCREWS AND VERTEBROPLASTY OF THE SAME LEVELS. CODE: 283910000 ; LOT: NOT INFORMED, CODE: 199723850 (02 UNITS) ; LOT: NOT INFORMED, CODE: 199723840 (02 UNITS) ; LOT: NOT INFORMED. CONCOMITANT DEVICE REPORTED: CONFIDENCE SPINAL CEMENT SYSTEM (PART# 283910000, LOT# UNKNOWN, QUANTITY 1). UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) . THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

    Patient problems: Tissue Damage

    MAUDE report 9191936 ↗
  • InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EVENT: SCREWS WERE CHANGED AT LEVELS L2 AND S1, BECAUSE EXPEDIUM SCREWS WERE FENESTRATED, CONFIDENCE CEMENT WAS PLACED ON THE FENESTRATED SCREWS, AT THE TIME OF FINISHING PLACING THE CONFIDENCE CEMENT INSIDE THE SCREWS A CONTROL PLATE WAS TAKEN IN WHERE IT WAS NOTICED THAT THE CEMENT CAME OUT OF THE VERTEBRAL BODY THROUGH THE LOWER HOLE OF THE SCREW AT LEVEL S1. DIAGNOSIS: POST-OPERATED UNSTABLE LUMBAR COLUMN + SCREW EXTRUSION L2-S1 BILATERAL. SURGERY: CHANGE OF BILATERAL L2 AND S1 SCREWS WITH CANNULATED SCREWS AND VERTEBROPLASTY OF THE SAME LEVELS. CODE: 283910000 ; LOT: NOT INFORMED, CODE: 199723850 (02 UNITS) ; LOT: NOT INFORMED, CODE: 199723840 (02 UNITS) ; LOT: NOT INFORMED. CONCOMITANT DEVICE REPORTED: CONFIDENCE SPINAL CEMENT SYSTEM (PART# 283910000, LOT# UNKNOWN, QUANTITY 1) UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

    Patient problems: Tissue Damage

    MAUDE report 9191848 ↗

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Sources and updates

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