VIPER PRIME 186770435SRecalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034530239), received between May 28, 2025 and May 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Numbness2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.
Patient problems: Numbness; Pain
MAUDE report 22094519 ↗InjuryMay 28, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.
Patient problems: Numbness; Pain
MAUDE report 22094518 ↗
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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