Skip to content

VIPER 186717740Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 x 7.0 x 40mm · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034123639), received between Jun 12, 2018 and Jun 12, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break2

Patient problems

  • Not Applicable2
  • Spinal Column Injury2

Recent adverse event reports

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

  • InjuryJun 12, 2018Break; Break

    ON (B)(6) 2017, THE SURGERY FOR TRAUMATIC INJURY WAS PERFORMED BY USING THE VIPER 2 SPINE SYSTEM. THE FIXED AREA WAS L1. ON (B)(6) 2018, DURING THE PLANNED REMOVAL SURGERY, IT WAS FOUND THAT 2 X VIPER MONO SCREW ((B)(4)) HAD BEEN BROKEN AT THE BASE OF ITS SCREW HEAD. THE TWO BROKEN SCREWS WERE EXTRACTED BY REMOVING THE AREA AROUND THE TWO BROKEN SCREWS USING A CHISEL. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTS THAT THIS EVENT MAY HAVE OCCURRED BECAUSE THE SCREWS WERE IN UNSTABLE POSITION CAUSED BY VERTEBRAL NONUNION.

    Patient problems: Not Applicable; Spinal Column Injury

    MAUDE report 7591715 ↗
  • InjuryJun 12, 2018Break; Break

    ON (B)(6) 2017, THE SURGERY FOR TRAUMATIC INJURY WAS PERFORMED BY USING THE VIPER 2 SPINE SYSTEM. THE FIXED AREA WAS L1. ON (B)(6) 2018, DURING THE PLANNED REMOVAL SURGERY, IT WAS FOUND THAT 2 X VIPER MONO SCREW (186717740) HAD BEEN BROKEN AT THE BASE OF ITS SCREW HEAD. THE TWO BROKEN SCREWS WERE EXTRACTED BY REMOVING THE AREA AROUND THE TWO BROKEN SCREWS USING A CHISEL. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTS THAT THIS EVENT MAY HAVE OCCURRED BECAUSE THE SCREWS WERE IN UNSTABLE POSITION CAUSED BY VERTEBRAL NONUNION.

    Patient problems: Not Applicable; Spinal Column Injury

    MAUDE report 7591600 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.