EXPEDIUM VIPER 196789120Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034295237), received between Oct 31, 2019 and Oct 31, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2019Break; Break
A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) PROCEDURE WAS PERFORMED TO STABILIZE TH12-S DUE TO SCOLIOSIS ON (B)(6) 2017. ON AN UNKNOWN DATE, THE RODS (196789120) HAD BEEN BROKEN. ON (B)(6) 2019, THE PATIENT WILL UNDERGO A REVISION PROCEDURE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.
Patient problems: No Code Available
MAUDE report 9261054 ↗InjuryOct 31, 2019Break; Break
A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) PROCEDURE WAS PERFORMED TO STABILIZE TH12-S DUE TO SCOLIOSIS ON (B)(6) 2017. ON AN UNKNOWN DATE, THE RODS (196789120) HAD BEEN BROKEN. ON (B)(6) 2019, THE PATIENT WILL UNDERGO A REVISION PROCEDURE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.
Patient problems: No Code Available
MAUDE report 9261031 ↗
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 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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.
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