VIPER 279726508Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034199566), received between Jul 2, 2018 and Jan 19, 2024 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionJan 19, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT BEFORE A POSTERIOR LUMBAR FIXATION SURGERY ON (B)(6) 2024, THE PACKAGING WAS OPENED, AND IT WAS NOTED THAT THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED SCREW MIS CANNULA 16G X 228MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545210 ↗
• MalfunctionOct 22, 2021Break; Break

  ADDITIONAL EVENT INFORMATION: IT WAS REPORTED ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, TWO PRODUCTS WERE BROKEN. IT WAS UNKNOWN HOW IT WAS OCCURRED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683312 ↗
• MalfunctionOct 22, 2021Break; Break

  DEVICE REPORT FROM POLAND (B)(6) AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT TWO PRODUCTS WERE BROKEN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED SCREW MIS CANNULA 16G X 228MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683216 ↗
• InjuryMay 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE PART OF THE CANNULA WAS BROKE AND STAYED INSIDE THE PATIENT AS IT COULDN¿T EXTRACTED ANYMORE. THE OUTCOME OF PROCEDURE AND THE PATIENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10032707 ↗
• DeathJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). DURING THE SURGERY WITH VIPER 2 SYSTEM, THE PATIENT WENT INTO THE CARDIAC ARREST, FOLLOWED BY THE REANIMATION THAT WAS NOT SUCCESSFUL. THE PATIENT WAS AN OLDER FEMALE, 85 YEARS OLD, WITH BECHTEREW DISEASE. THE SURGERY WAS ALMOST FINISHED AT THE TIME OF THE EVENT, WITH ALL THE SCREWS INSERTED AND FINISHED VERTEBROPLASTY IN 6 VERTEBRAL BODIES. THE 12 VIPER SCREWS/INNIES, 2 TITANIUM RODS, 3 CONFIDENCE CEMENTS. OR DOCTOR PROVIDED A MEDICAL RATIONALE THAT INDICATES THE USE OF THE PRODUCT IS IN NO WAY RELATED TO THE REPORTED EVENT: THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS THAT COULD POTENTIALLY RESULT IN THE OUTCOME.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7655626 ↗