VIPER 286725410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034214399), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 malfunction.

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. 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.

• MalfunctionJun 28, 2018Break; Break

  DURING A MIS PROCEDURE, THE SURGEON WAS ATTEMPTING TO EXTRACT A VIPER2 INNER NUT TO REPOSITION ROD. THE NUT BECAME STRIPPED. UPON THE SURGEON¿S ATTEMPT TO RETRIEVE SAID INNER NUT, THE TIP OF THE X25 NUT INSERTER BROKE IN THE HEX OF THE INNER NUT. UNABLE TO RETRIEVE, THE SURGEON OPTED TO LEAVE THE NUT AND THE WEDGED BROKEN TIP IN THE PATIENT TO AVOID ADDITIONAL ISSUES. PATIENT CONSEQUENCE? UNKNOWN. 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 7645823 ↗