VIPER PRIME 186750435SRecalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 35mm · Class 2 · Implant
All models of VIPER PRIME (60)
Data updated Oct 16, 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 10705034529936), received between Aug 21, 2023 and Sep 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2024, DURING A POSTERIOR SPINAL FUSION THE VIPER PRIME FENESTRATED SCREW IN QUESTION COULD NOT BE SUCCESSFULLY ATTACHED TO A SCREWDRIVER. EVEN WITH A DIFFERENT SCREWDRIVER, THE VIPER PRIME FENESTRATED SCREW IN QUESTION COULD NOT BE ATTACHED. THEN, THE SURGEON ATTACHED ANOTHER SCREW THAT WAS SUPPOSED TO BE USED IN ANOTHER STAGE TO THE SCREWDRIVER AND MADE SURE IT COULD BE ATTACHED. THEREFORE, A NEW SCREW OF THE SAME SIZE AS THE SCREW IN QUESTION WAS OPENED AND ATTACHED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS REPORT AS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20244913 ↗MalfunctionAug 21, 2023Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A DEFECTIVE SCREW IN THE LONER KIT. THE THREAD WAS DEFECTIVE, AND THE SCREW COULD NOT BE CLAMPED IN THE SCREWDRIVER. THERE WAS NO PATIENT HARM. THE EVENT HAPPENED DURING SURGERY. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17584975 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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