VIPER 186788045SRecalls & reported problems
Medos International Sàrl · VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 45mm · Class 2 · Implant
All models of VIPER (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034238227), received between Feb 10, 2023 and Feb 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2023Migration; Migration
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FINLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT A SURGEON FROM HUS TÖÖLÖ NEUROSURGERY WARD CONTACTED ME YESTERDAY EVENING ABOUT A VIPER PRIME L5/S1 FUSION WE DID ON (B)(6) 2022. THE RODS HAD SLIPPED OUT OF THE L5 SCREW AND THE VERTEBRAE HAS SLIPPED TO THE SAME POSITION AS IT WAS PREOPERATIVELY. I AM WAITING FOR POSSIBLE FURTHER INFORMATION BUT THIS IS ALL I KNOW AT THIS POINT. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-45MM. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16358193 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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