VIPER PRIME 186750445Recalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 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
- 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 10705034509198), received between Sep 3, 2024 and Sep 3, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Entrapment of Device2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS IDENTIFIED BEFORE THE CASE THAT THREE SCREWS HAD BROKEN POSTOPERATIVELY IN THE PATIENT. TWO VIPERS PRIME CFXFEN XTAB 5X45MM BROKE AT THE T12 LEVEL AND ONE VIPER PRIME CFXFEN XTAB 6X45MM BROKE AT THE L2 LEVEL ON THE LEFT. ALL SCREWS WERE REMOVED. THE THREE BROKEN SCREWS WERE MOSTLY REMOVED, BUT FRAGMENTS WERE LEFT IN THE VERTEBRAE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 45MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 20125508 ↗InjurySep 3, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS IDENTIFIED BEFORE THE CASE THAT THREE SCREWS HAD BROKEN POSTOPERATIVELY IN THE PATIENT. TWO VIPERS PRIME CFXFEN XTAB 5X45MM BROKE AT THE T12 LEVEL AND ONE VIPER PRIME CFXFEN XTAB 6X45MM BROKE AT THE L2 LEVEL ON THE LEFT. ALL SCREWS WERE REMOVED. THE THREE BROKEN SCREWS WERE MOSTLY REMOVED, BUT FRAGMENTS WERE LEFT IN THE VERTEBRAE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 45MM. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 20125506 ↗
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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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