EXPEDIUM VERSE 199721660Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 x 60mm · Class 2 · Implant
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034442242), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- 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 12, 2019Crack; Crack
DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2019, AT THE TIME OF PLACING THE DOUBLE-PASS BUSHING TO THE SCREW, IT LOOKED 6.0X60MM AND IT DID NOT REACH A STOP. WHEN TRYING TO GIVE IT THE FINAL TORQUE, IT WAS NOT POSSIBLE. ANOTHER DOUBLE-PASS BUSHING WAS PASSED, AND IT PASSED THE SAME AS THE FIRST ONE AND IT IS EVIDENCED AS THREADS OF TITANIUM THAT CAME OUT WHEN PLACING THE BUSHING. IT WAS ALSO TRIED WITH A SIMPLE BUSHING AND THE SAME THING HAPPENED; THE SCREW FINS ARE BROKEN, AND THE BUSHING WAS TRIED TO BE PLACED BUT WAS NOT POSSIBLE. IT WAS DECIDED TO CHANGE THE SCREW FOR ANOTHER ONE SINCE SEVERAL ATTEMPTS WERE MADE WITH NO SUCCESS. THE SCREW WAS CHANGED AND ONE OF THE PREVIOUSLY USED BUSHINGS WAS USED. THIS REPORT IS FOR AN EXPEDIUM® VERSE SPINE SYSTEM SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9309811 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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.
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