VIPER PRIME 186750440SRecalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 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
- 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 10705034529943), received between Feb 18, 2026 and Apr 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem1
- Migration1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Nonstandard Device; Compatibility Problem
IT WAS REPORTED THAT THIS WAS A FLIF (TH11-L4) FOR AN OVF ON (B)(6) 2026. DURING THE SURGERY, THE TIP OF THE SCREWDRIVER COULD NOT BE INSERTED INTO THE HOLE OF THE SCREW, AND THE SCREW COULD NOT BE INSTALLED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING ANOTHER NEW SCREW. THE SCREW IN QUESTION WAS CHECKED AFTER THE SURGERY, AND IT WAS CONFIRMED THAT THE SCREW HOLE IS PENTAGONAL, NOT HEXAGONAL, AND ONE GROOVE IS MISSING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845414 ↗MalfunctionFeb 18, 2026Migration
IT WAS REPORTED THAT THIS WAS A POSTERIOR THORACIC FUSION (TH6) FOR THORACIC MYELOPATHY ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, CEMENT LEAKAGE DUE TO SCREW PERFORATION OF THE ANTERIOR VERTEBRAL CORTEX WAS CONFIRMED. AS THERE ARE NO SYMPTOMS AT PRESENT, NO ADDITIONAL TREATMENT HAS BEEN PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Tissue Injury
MAUDE report 24376892 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page