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VIPER 186731550Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 x 50mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034351643), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Disconnection1
  • Material Split, Cut or Torn1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryNov 1, 2018Disconnection; Material Split, Cut or Torn; Disconnection; Material Split, Cut or Torn

    IT WAS REPORTED THE VIPER CORTICAL FIX SCREW 1867-31-550¿S TULIP HEAD DISENGAGED FROM THE SHANK. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: SCREW WAS SUCCESSFULLY REMOVED. 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 8029731 ↗

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