VIPER 186727540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034282442), received between Sep 9, 2021 and Sep 9, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR PSEUDARTHROSIS AND CORRECTION OF SAGITAL BALANCE, THE PATIENT HAS HAD SPINAL SURGERY MANY TIMES BEFORE BY DIFFERENT SPINE SURGEONS. IT WAS OBSERVED THAT THREE (3) OF THE THORACAL SCREWS FROM A PREVIOUS SURGERY, LEVELS TH9 AND TH12, ALL PERFORATED AND CEMENTED CFX 5.0MM WERE BROKEN IN THE MIDDLE PART OF THE SCREW SHAFT, JUST ABOUT AT THE FIRST PERFORATION. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12447281 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR PSEUDARTHROSIS AND CORRECTION OF SAGITAL BALANCE, THE PATIENT HAS HAD SPINAL SURGERY MANY TIMES BEFORE BY DIFFERENT SPINE SURGEONS. IT WAS OBSERVED THAT THREE (3) OF THE THORACAL SCREWS FROM A PREVIOUS SURGERY, LEVELS TH9 AND TH12, ALL PERFORATED AND CEMENTED CFX 5.0MM WERE BROKEN IN THE MIDDLE PART OF THE SCREW SHAFT, JUST ABOUT AT THE FIRST PERFORATION. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 40MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12447223 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR PSEUDARTHROSIS AND CORRECTION OF SAGITAL BALANCE, THE PATIENT HAS HAD SPINAL SURGERY MANY TIMES BEFORE BY DIFFERENT SPINE SURGEONS. IT WAS OBSERVED THAT THREE (3) OF THE THORACAL SCREWS FROM A PREVIOUS SURGERY, LEVELS TH9 AND TH12, ALL PERFORATED AND CEMENTED CFX 5.0MM WERE BROKEN IN THE MIDDLE PART OF THE SCREW SHAFT, JUST ABOUT AT THE FIRST PERFORATION. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 40MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12446791 ↗