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VIPER 186727045Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 10 x 45mm · Class 2 · Implant

All models of VIPER (121)

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034282343), received between Jun 17, 2022 and Jul 1, 2022 — classified as 2 malfunctions.

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
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 1, 2022Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT HAD PREVIOUS L5-S1 INSTRUMENTATION. 7.5MM X 45MM SCREWS WAS TAKEN OUT ON BOTH L5 PEDICLES. AFTER TAPPING SEQUENTIALLY FROM 7.0MM, 8.0MM, 9.0MM DUEL LEAD TAPS, THEY ATTEMPTED TO IMPLANT THE RIGHT PEDICLE L5 SCREW WITH A 10.0X45MM CORTICAL FIX FENESTRATED SCREW. THEY NEEDED TO DRIVE THE SCREW IN FURTHER AFTER INITIALLY STOPPING THEIR FORWARD MOMENTUM, AFTER HEARING A COUPLE CLICKS THE TULIP "HEAD" OF THE SCREW DISENGAGED FROM THE SCREW SHAFT, LEAVING THE SCREW SHAFT INSIDE THE PEDICLE. THE SCREW SHAFT WAS TAKEN OUT OF THE PATIENT AND REPLACE IT WITH ANOTHER EXACT SAME SIZE SCREW, ONLY THE SECOND TIME AROUND HE TAPPED TO A LONGER LENGTH. THE TIP OF SCREW DRIVER BROKE AS THEY ATTEMPTED TO DRIVE THE SCREW INTO BONE. THEY COULD NOT REMOVE SHAFT OF SCREW FROM THE REMOVAL TOOL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 10X45. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14888057 ↗
  • MalfunctionJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE VIPER II CFX SCREW FAILED AND WHEN TIGHTENING THE POLYAXIAL HEAD CAME OFF THE SHAFT. THERE WAS A SURGICAL DELAY OF TWENTY MINUTES. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT INVOLVES ONE UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES: VIPER 2. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14733024 ↗

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Sources and updates

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