VIPER 186717550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034123318), received between May 26, 2023 and May 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF (L2) FOR BURST FRACTURE OF L1 ON (B)(6) 2023. PPS WAS DONE AT TH10-L2, AND THE SCREWS IN QUESTION WERE USED ON BOTH SIDES OF L2. XTAB CFS WAS INSERTED IN TH10, MONO SCREWS WERE INSERTED IN TH12, WITH TH10 AND TH12 IN FINAL TIGHTENING, A V3D DISTRACTOR WAS USED TO STRETCH BETWEEN TH12/L2. AFTER DISTRACTION WAS DONE, THE SURGEON TIGHTENED THE SCREWS FURTHER WITH A SCREWDRIVER AND TRIED THE FINAL TIGHTENING OF SCREWS, THE SCREWS SEEMED TO GET STRIPPED. THE SCREWS WERE REMOVED AND THE THREADS ON THE SCREWS WERE FOUND TO BE DAMAGED. THE SURGEON USED OTHER SET SCREWS AND TRIED TO DO THE FINAL TIGHTENING, BUT THE SITUATION DID NOT CHANGE. THEREFORE, THE SALES REP RECOMMENDED THE REMOVAL OF THE SCREWS. THE SURGEON REMOVED THE SCREWS AT THE SURGEON¿S DISCRETION, INSERTED OTHER SCREWS, DID THE DISTRACTION CAREFULLY, AND DID THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 90 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 5X50MM TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009939 ↗
• MalfunctionMay 26, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF (L2) FOR BURST FRACTURE OF L1 ON (B)(6) 2023. PPS WAS DONE AT TH10-L2, AND THE SCREWS IN QUESTION WERE USED ON BOTH SIDES OF L2. XTAB CFS WAS INSERTED IN TH10, MONO SCREWS WERE INSERTED IN TH12, WITH TH10 AND TH12 IN FINAL TIGHTENING, A V3D DISTRACTOR WAS USED TO STRETCH BETWEEN TH12/L2. AFTER DISTRACTION WAS DONE, THE SURGEON TIGHTENED THE SCREWS FURTHER WITH A SCREWDRIVER AND TRIED THE FINAL TIGHTENING OF SCREWS, THE SCREWS SEEMED TO GET STRIPPED. THE SCREWS WERE REMOVED AND THE THREADS ON THE SCREWS WERE FOUND TO BE DAMAGED. THE SURGEON USED OTHER SET SCREWS AND TRIED TO DO THE FINAL TIGHTENING, BUT THE SITUATION DID NOT CHANGE. THEREFORE, THE SALES REP RECOMMENDED THE REMOVAL OF THE SCREWS. THE SURGEON REMOVED THE SCREWS AT THE SURGEON¿S DISCRETION, INSERTED OTHER SCREWS, DID THE DISTRACTION CAREFULLY, AND DID THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 90 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 5X50MM TI. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009935 ↗