VIPER 279704100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034301259), received between Jun 2, 2020 and Jun 2, 2020 — classified as 1 injury.

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

• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEONS WERE REVISING A PREVIOUS SURGERY THAT HAD DEVELOPED PJK AND SHOWED SIGNS OF ILIAC SCREW FAILURE. THE PATIENT'S INITIAL FUSION (PERFORMED ON (B)(6) 2019) WAS FROM T11-ILIUM, WITH EXPEDIUM 5.5 AND CORTICAL FIX IMPLANTS PLACED FROM T11-L5, AND NUVASIVE RELINE ILIAC BOLTS PLACED FOR THE S2 SAI SCREWS (8.5 X 80MM SCREWS). ON (B)(6) 2020, THE SURGEON REMOVED THE NUVASIVE ILIAC BOLTS (FROM THE PATIENT'S RIGHT SIDE) AND INTENDED TO IMPLANT DSS VIPER SAI ILIAC SCREWS (1797-04-XXX). HE USED A VIPER 9.0 TAP (2797-04-900) AND THE SURGEON PROCEEDED TO PASS A 10MM SAI TAP (2797-04-100) DOWN THROUGH THE PREPARED PATHWAY, AND HE REQUESTED A 11X80MM ILIAC SCREW AND PROCEEDED TO IMPLANT THE 1797-12-280 SCREW. AS THE SCREW ADVANCED THROUGH THE PRIOR PATHWAY, HE FELT THE SCREW WAS NOT ADVANCING THROUGH THE BONE. AT THIS TIME, HE ATTEMPTED TO REMOVE THE ILIAC BOLT FROM THE BONE BUT WAS UNABLE TO ADVANCE THE SCREW IN EITHER DIRECTION (CLOCKWISE OR COUNTERCLOCKWISE). IN THIS PROCESS, THE POLYAXIAL SCREW HEAD BROKE FROM THE ILIAC BOLT AND WAS REMOVED FROM THE PATIENT. ATTEMPTED TO REMOVE THE

  Patient problems: Injury; No Code Available

  MAUDE report 10111281 ↗