VIPER 186727545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034282459), received between Dec 29, 2020 and Feb 18, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE VCFFX SCREW COULD NOT BE LOCKED WITH SET SCREW. THERE WAS A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379850 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SPAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, THE PATIENT UNDERWENT AN OPERATION WITH THE PRODUCTS IN QUESTION. THE PATIENT¿S RADICULAR PAIN IMPROVED AFTER THE SURGERY, BUT THEY HAVE SINCE HAD DISABLING LUMBAR PAIN. TESTS PERFORMED WITH X-RAY AND CT SCAN WERE NORMAL. THE PATIENT SUSPECTS THEY HAVE AN ALLERGY TO TITANIUM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 45MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18277339 ↗
• InjuryMay 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON AN UNKNOWN DATE IN 2016 TO TREAT A FRACTURE. ON (B)(6) 2023, THREE SCREWS WERE FOUND TO BE BROKEN. THE SURGEON STATED THAT THEY BROKE DUE TO BEING IN THE PATIENT FOR TOO LONG AND THAT THEY SHOULD HAVE BEEN REMOVED 12 MONTHS POSTOPERATIVELY. THE METALWARE WAS REMOVED, AND BROKEN SCREW SHAFTS REMAINED THE PATIENT. NOTHING NEW WAS IMPLANTED; THE GOAL OF THE ORIGINAL FIXATION HAD BEEN ACHIEVED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 45MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16852747 ↗
• InjuryMay 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON AN UNKNOWN DATE IN 2016 TO TREAT A FRACTURE. ON (B)(6) 2023, THREE SCREWS WERE FOUND TO BE BROKEN. THE SURGEON STATED THAT THEY BROKE DUE TO BEING IN THE PATIENT FOR TOO LONG AND THAT THEY SHOULD HAVE BEEN REMOVED 12 MONTHS POSTOPERATIVELY. THE METALWARE WAS REMOVED, AND BROKEN SCREW SHAFTS REMAINED THE PATIENT. NOTHING NEW WAS IMPLANTED; THE GOAL OF THE ORIGINAL FIXATION HAD BEEN ACHIEVED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 45MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16852741 ↗
• MalfunctionDec 29, 2020Crack; Crack

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, CROSS THREADING OF SCREW CAP LEADING TO TULIP HEAD OF SCREW DAMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 5X45. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088097 ↗