VIPER PRIME 186760245Recalls & reported problems
Medos International Sàrl · VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 x 45mm · Class 2 · Implant
All models of VIPER PRIME (60)
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 10705034509266), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS PLACING THE L5 PEDICLE SCREW ON THE PATIENT'S RIGHT USING THE VIPER PRIME SYSTEM. WHEN THE SURGEON CONFIRMED THE TIP OF THE SCREW/DRIVER ASSEMBLY WAS PROPERLY POSITIONED VIA INTRA-OPERATIVE FLUORO, HE ADVANCED THE PRIME STYLET APPROXIMATELY 3MM IN THE PEDICLE AND USED A MALLET TO ADVANCE THE EXTENDED STYLET UNTIL IT WAS FULLY SEATED. THE SURGEON FELT THAT WHEN HE DEPLOYED THE STYLET TO APPROXIMATELY 15MM, HE WAS UNABLE TO CONTINUE TO ADVANCE THE STYLET DUE TO HARD BONE. THE SURGEON CONFIRMED WITH INTRO-OPERATIVE FLUORO THAT THE STYLET WAS NOT ADVANCING, AND IT BECAME EVIDENT FROM THE IMAGE THAT THE STYLET WAS BENT AT THE DISTAL END OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE SCREW/DRIVER/STYLET ASSEMBLY FROM THE PEDICLE. ONCE REMOVED FROM THE INCISION, THE STAFF ATTEMPTED TO REMOVE THE BENT STYLET FROM THE SCREW/DRIVER ASSEMBLY. WHILE THE STAFF CONTINUED TO ATTEMPT TO REMOVE THE BENT STYLET, THEY ASSEMBLED A NEW DRIVER/STYLET, AND PROCEEDED TO LOAD A NEW 6.0X45MM PRIME SCREW. THE SURGEON INSERTED THE NEW SCREW WITH NEW DRIVER ASSEMBLY WITH NO FURTHER ISSUES. AFTER THE PROCEDURE WAS COMPLETED, TH
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10809285 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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