VIPER 186731435Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034351414), received between Feb 25, 2021 and Sep 13, 2023 — classified as 5 injuries.

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

• 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, OPERTING ROOM 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 4.35 X 35MM. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735847 ↗
• 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 4.35 X 35MM. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735828 ↗
• 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 4.35 X 35MM. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735821 ↗
• 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 4.35 X 35MM. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735747 ↗
• InjuryFeb 25, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW AT THE T6 PEDICLE HAD CUT OUT AND DEVIATED INTO THE SPINAL CANAL. ON (B)(6) 2020 THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION, SCREWS WERE DEPLOYED AT T6 LEFT, T7 AND T8. AT THE END OF (B)(6) 2021, THE PATIENT EXPERIENCED PARALYSIS IN THE LOWER LIMBS DUE TO THE MIGRATION OF THE SCREW. ON (B)(6) 2021 THE SCREW THAT HAD MIGRATED WAS REMOVED. CONCOMITANT DEVICE REPORTED: ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Paralysis

  MAUDE report 11377820 ↗