EXPEDIUM VERSE 199723550Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 x 50mm · 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 10705034403243), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Failure of Implant1
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2020Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, REVISION SURGERY WAS PERFORMED FOR REMOVAL OF A BROKEN SCREW USED IN A STABILIZATION PRIMARY SURGERY ON (B)(6) 2019. A NEW SCREW WAS REPLACED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN SETSCREWS PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT WILL CAPTURE THE POST-OP EVENT (REVISION SURGERY DUE TO REMOVAL OF A BROKEN SCREW) WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT (IT WAS NOT POSSIBLE TO EXTRACT THE FRAGMENT DURING REVISION SURGERY). THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; Foreign Body In Patient; No Code Available
MAUDE report 9701901 ↗
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.