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VIPER 186719865Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM CLOSED POLYAXIAL SCREW 5.5 8 x 65mm · Class 2 · Implant

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 10705034280356), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE INTERVENTION, 2 SCREWS DISASSEMBLED IN SITU. ANOTHER IMPLANTS WERE USED TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CLOSED POLYAXIAL SCREW 5.5 8 X 65MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17192874 ↗

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.