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VIPER 186727630Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 6 x 30mm · 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 10705034282534), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 injury.

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 Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryJan 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE VIPER E CORTICAL FIX SYSTEM WAS REMOVED ON (B)(6) 2019, DUE TO LOW BACK PAIN FOLLOWING PHYSICAL ACTIVITY. IT WAS DETERMINED THAT THE PEDICLE SCREW WAS BROKEN IN L5, THEREFORE THE IMPLANT WAS REMOVED AFTER HEALING OF THE L2 L3 L4 FRACTURES. THE SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 DUE TO A FRACTURE OF THE L2/L3/L4. DURING MANUFACTURER'S PRELIMINARY ASSESSMENT ON JANUARY 7, 2020, OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT THE SADDLE IN THE TULIP HEAD OF THE CORTICAL FIX POLYAXIAL SCREW HAS BEEN DISLOCATED. CONCOMITANT DEVICE REPORTED: ROD, (PART# 1867-89-120, LOT# TBFAP, QUANTITY 2). POLYAXIAL SCREW 6X30, (PART# 1867-27-630, LOT# 184676, QUANTITY 3). POLYAXIAL SCREW 6X45, (PART# 1867-27-645, LOT# 168857, QUANTITY 3). SINGLE- INNER SET SCREW, (PART# 1867-15-000, LOT# 194154, QUANTITY 2). SINGLE-INNER SET SCREW, (PART# 1867-15-000, LOT# 182988, QUANTITY 4). SINGLE-INNER SET SCREW, (PART# 1867-15-000, LOT# 181885, QUANTITY 1). SINGLE-INNER SET SCREW, (PART# 1867-15-000, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 6X30. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Code Available; Pain

    MAUDE report 9574780 ↗

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