VIPER 186720530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034125602), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UNIPLANAR SCREWS WERE REMOVED FROM THE PATIENT THAT FOUND TO BE SLIGHTLY BENT AT COLLAR LEVEL, IT WAS PERPENDICULAR FROM THE NATURAL SCREWHEAD AXIS. IT WAS ALSO IMPORTANT TO NOTE: THE ABLATION OF THESE SCREWS HAS NO RELATIONSHIP, NOR REASONS, WITH THE BENDING ISSUE ANNOUNCED IN THIS COMPLAINT. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED UNIPLANAR SCREW 5.5 X 5.0 X 30MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11655790 ↗