VIPER 186717745Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034123646), received between Apr 14, 2021 and Aug 28, 2023 — classified as 2 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. 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.

• InjuryAug 28, 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: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE ROD BREAKAGE FOUND IN THE REMOVAL SURGERY ON (B)(6), 2023. THIS PC REPORTS ABOUT THE SCREW REPLACEMENT PERFORMED IN THE REVISION SURGERY ON (B)(6), 2021. IT WAS REPORTED THAT THIS WAS A PPS (L3-5) FOR A FRACTURE OF L4 ON (B)(6), 2021. AFTER THE INITIAL SURGERY, A REVISION SURGERY WAS PERFORMED ON (B)(6), 2021, AND THE VIPER MONOAXIAL SCREW 7×45 MM INSERTED INTO L3 RIGHT WAS REPLACED WITH A PRIME SCREW 7×45 MM. THE PATIENT STATUS/ OUTCOME WERE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 7X45MM TI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17633558 ↗
• InjuryApr 14, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON MAR. 8, 2021 IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION AT L3 LEFT TREATING INTERBODY FRACTURE. ON MAR. 15 THE PATIENT WAS X-RAYED IN THE MEDICAL FOLLOW-UP. IT WAS FOUND THAT THE SETSCREW AT L3 HAD COME OFF. ON MAR. 17 THE PATIENT UNDERWENT A REVISION PROCEDURE. THEY ALSO FOUND THAT THE INSIDE OF THE MONOAXIAL SCREW HAD BEEN DAMAGED. NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. THE SURGEON COMMENTED THAT THE PATIENT HAD A LARGE PHYSIQUE WHICH MIGHT HAVE PUT STRESS TO THE DEVICES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 7X45MM TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11666183 ↗