VIPER 186731545Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 x 45mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034351636), received between May 8, 2018 and May 8, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disassembly” (2 reports).
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
- Disassembly2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2018Disassembly; Disassembly
DURING SCREW INSERTION, SURGEON USED EXPEDIUM QUICK CONNECT POLYAXIAL SCREWDRIVER T20 TO REMOVE AND ADJUST THE PLACEMENT OF SCREWS A COUPLE OF TIME. THE DAMAGE SCREW WAS DISCOVERED DURING THE INSERTION OF ROD. THE DAMAGED SCREW HAS TO BE REMOVED AS IT OBSTRUCTED THE PLACEMENT OF ROD. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7496148 ↗MalfunctionMay 8, 2018Disassembly; Disassembly
DURING SCREW INSERTION, SURGEON USED EXPEDIUM QUICK CONNECT POLYAXIAL SCREWDRIVER T20 TO REMOVE AND ADJUST THE PLACEMENT OF SCREWS A COUPLE OF TIME. THE DAMAGE SCREW WAS DISCOVERED DURING THE INSERTION OF ROD. THE DAMAGED SCREW HAS TO BE REMOVED AS IT OBSTRUCTED THE PLACEMENT OF ROD. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7496125 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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