EXPEDIUM VERSE 199723630Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 x 30mm · Class 2 · Implant
- 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 10705034403113), received between Apr 26, 2018 and Apr 26, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Torn Material” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Torn Material1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2018Torn Material; Torn Material
L4-S1 POSTEROLATERAL FUSION (B)(6) PRIVATE HOSPITAL (B)(6) 2018. THREE X SCREWS WERE PLACED ON THE LEFT SIDE AT L4/5/S1 AND THE RODS AND CORRECTION KEYS HAD ALSO BEEN PLACED AND FINAL TIGHTENED. DURING THE FINAL STEP OF BREAKING OFF THE EXTENDED TABS OF THE LEFT L5 VERSE SCREW ONE TAB BROKE BELOW THE INDICATED BREAKING POINT. IN DOING SO THE CORRECTION KEY WAS NO LONGER RETAINING THE ROD SECURELY WITHIN THE HEAD OF THE SCREW. THE SURGEON REMOVED THE OTHER 2 X CORRECTION KEYS AT L4 AND S1 AND ROD FROM THE LEFT SIDE CONSTRUCT TO ALLOW HIM TO REMOVE THE LEFT L5 VERSE PEDICAL SCREW. SURGEON THEN REPLACED A NEW SCREW, ROD AND CORRECTION KEYS AND AGAIN FINAL TIGHTENED THE CONSTRUCT. THE BREAKING OF THE TABS WAS THEN SUCCESSFUL AND OPERATION WAS COMPLETED. SURGEON HAPPY WITH END RESULT OF THE OPERATION. TEN MINUTES DELAY TO PROCEDURE, NO AE TO PATIENT MALE PATIENT (B)(6).
Patient problems: Not Applicable
MAUDE report 7463939 ↗
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 199723535Medos International Sàrl · bone cement, posterior screw augmentation4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.