VIPER 186760050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034129211), received between Apr 7, 2021 and Apr 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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. 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.

• MalfunctionApr 7, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO UNITS OF MIS CANNULATED X-TAB 6X50MM TI WERE RECEIVED AND IDENTIFIED THAT THE X-TAB ON BOTH DEVICES WERE CUT OFF. THERE IS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627771 ↗
• MalfunctionApr 7, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO UNITS OF MIS CANNULATED X-TAB 6X50MM TI WERE RECEIVED AND IDENTIFIED THAT THE X-TAB ON BOTH DEVICES WERE CUT OFF. THERE IS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627766 ↗