VIPER 186727655Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034282589), received between Jul 2, 2018 and Dec 16, 2025 — classified as 2 deaths, 1 injury.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.

  Patient problems: Pain

  MAUDE report 23823895 ↗
• DeathJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTER: (B)(6). TRAUMA SURGEON (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, (B)(6) 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. OPERATING ROOM 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 7655471 ↗
• DeathJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTER: (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, (B)(6), 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. TWELVE (12) VIPER SCREWS/INNIES, 2 TITANIUM RODS, 3 CONFIDENCE CEMENTS. OPERATING ROOM (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 7654666 ↗