EXPEDIUM 179712555Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 5 x 55mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034067582), received between Oct 21, 2022 and Oct 21, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2022Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS OPERATED 2 YEARS AGO WITH LUMBAR SPINE FUSION (USING 7 PEDICLE SCREWS). PATIENT CAME BACK TO THE NEUROSURGEON A MONTH AGO WITH A LOT OF PAIN. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED 3 BROKEN SCREWS. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2022 AND REPLACED 3 BROKEN SCREWS WITH A BIGGER DIAMETER OF 6.0 MM SCREW. ALSO HE CHANGED ANOTHER ONE SCREW OF 5.0 MM WITH A 6.0 MM SCREW. FINALLY HE DECIDED TO ADD 5 MORE SCREWS 4 AT THE THORACIC LEVELS AND ONE SCREW AT THE SACRUM SO AS TO EXPAND THE 2 LEVEL FUSION TO AN ADULT SCOLIOSIS OPERATION. THERE WAS A SURGICAL DELAY OF UNSPECIFIED AMOUNT AS SURGEON HAD TO USE DRILL AND KERISSON TOOL TO REMOVE BROKEN SCREWS. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 5 X 50MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Pain
MAUDE report 15653933 ↗
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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