VIPER 286715600NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034388496), received between Sep 6, 2018 and Jan 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING CLEANING, BONE MATTER COULD NOT BE REMOVED FROM THE INSTRUMENT. THIS REPORT INVOLVES ONE (1) UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203542 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED THAT, WHILE THE SURGEON WAS PREPPING THE PEDICLE WITH THE 6MM VIPER TAP, THE TAP BROKE OFF JUST ABOVE THE FIRST THREAD. THIS WAS DUE TO THE PATIENT HAVING VERY HARD BONE. PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850212 ↗