EXPEDIUM VERSE 199723440Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 x 40mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034403434), received between Nov 14, 2019 and Nov 14, 2019 — classified as 1 malfunction.
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
- Crack1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2019Break; Crack; Break; Crack
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FIXATION SURGERY ON AN UNKNOWN DATE, IT WAS NOTED THAT AFTER COMPLETING THE TOTAL SPINAL CONSTRUCT WITH THE EXPEDIUM VERSE ADVANCED SYSTEM AND TIGHTENING OF THE SETSCREWS, THE TABS WERE BROKEN OFF UNDER THE TOPNOTCH INSTEAD OF FLUSH WITH THE TOPNOTCH AS DESCRIBED IN THE SURGICAL TECHNIQUE. THIS CAUSED THE TOPNOTCH TO ALSO BREAK OFF THE SCREWHEAD. THE CONSTRUCT WAS LOOSENED, THIS SPECIFIC SCREW WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN EXPEDIUM VERSE 5.5 SCREW 4.35 X 40. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9321119 ↗
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.