EXPEDIUM VIPER 196788120Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 x 120mm · Class 2 · Implant
All models of EXPEDIUM VIPER (5)
Data updated Oct 18, 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 10705034182537), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K090648, K111136); they may or may not involve this specific model.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT A THIRD PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 X 120MM. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815321 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090648, K111136. One submission often covers many models, so check the product and lot details in each record.
- Z-1674-2015 · Apr 21, 2015 · TerminatedEXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page