VIPER 286740000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034214733), received between Feb 1, 2022 and Sep 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION FOR A SPINAL CANAL STENOSIS ON (B)(6) 2025, THE COMPRESSOR ARRIVED WITH PART BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027553 ↗
• MalfunctionApr 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE COMPRESSION SLEEVE AND FULCRUM ARE NOT SLIDING NICELY AND IS GETTING STUCK. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) COMPRESSOR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771257 ↗
• MalfunctionOct 14, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PIECE HAS A CRACK IN THE SPRING AND IS SUBJECT TO START IN THE NEXT SURGERY. THERE AS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM COMPRESSOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608365 ↗
• MalfunctionFeb 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS DAMAGED. NO ADDITIONAL INFORMATION AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE COMPRESSOR SPRING ASSEMBLY WAS BROKEN. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON JANUARY 31, 2022. THIS REPORT IS FOR ONE (1) VIPER SYSTEM COMPRESSOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416697 ↗