VIPER PRIME 186770440Recalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 40mm · Class 2 · Implant
All models of VIPER PRIME (60)
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 10705034509600), received between Mar 15, 2018 and Mar 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Disassembly” (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
- Disassembly1
Patient problems
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2018Disassembly; Disassembly
VIPER PRIME CORTICAL FIX SCREW DISASSEMBLED AND PREVENTED ROD FROM REDUCING. THIS REQUIRED REMOVAL OF ROD AND 2 ADDITIONAL SCREWS TO CORRECT THE ISSUE. NEW SCREWS WERE USED. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION: ADDITIONAL INCISION SIZE WAS NEEDED AND APPROXIMATELY 45 MIN WAS ADDED TO PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. ADDITIONAL CLARIFICATION FROM SALES REP: THE INTERNAL MECHANISM OF THE POLY FEATURE WAS NO LONGER WHERE IT WAS SUPPOSED TO BE. THE OTHER SCREW HAD PART OF THE THREAD SHEAR OFF PREVENTING A SET SCREW FROM ENGAGING. THIS WAS NOTICED AFTER ROD REMOVAL AND ATTEMPTS TO REPLACE SET SCREW WERE UNSUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7342347 ↗
Other Thoracolumbosacral pedicle screw system 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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