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VIPER 186727960Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 9 x 60mm · Class 2 · Implant

All models of VIPER (121)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034282923), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 28, 2021Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE SCREWING IN THE SCREW, THE SCREW HEAD CAME LOOSE FROM THE SCREW. THE SCREW WAS REPLACED WITHOUT HARM TO THE PATIENT. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 9 X 60MM. THIS IS REPORT 1 OF 1 FOR (B)(4)..

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12078934 ↗

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Sources and updates

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