VIPER 186731540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034351629), received between Sep 13, 2023 and Sep 13, 2023 — classified as 2 injuries.

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

• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PSF (POSTERIOR SPINAL FUSION) AT T9-L1 WAS PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE, OR TO REMOVE ALL THE IMPLANTS. IT WAS DECIDED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION IS COMPLETE. ALL IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 40MM. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735837 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PSF (POSTERIOR SPINAL FUSION) AT T9-L1 WAS PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE, OR TO REMOVE ALL THE IMPLANTS. IT WAS DECIDED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION IS COMPLETE. ALL IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 40MM. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735830 ↗