VIPER 186715745Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034122526), received between Nov 10, 2020 and Dec 5, 2023 — classified as 4 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM TAIWAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPERATION ON 13-NOVEMBER-2023, THE NAIL SCREW IN QUESTION COULD NOT BE TIGHTENED SUCCESSFULLY. THE SURGEON NEEDED TO TAKE ALL IMPLANTED HARDWARE OUT AND REPLACE THE NAIL SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18266837 ↗
• MalfunctionMar 29, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW HEAD THREAD WORE OUT UPON CAP CLOSING. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT, BUT WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639619 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT MIS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2019. AFTER TEN (10) DAYS, THE PATIENT DEVELOPED RASHES AND ITCHING ON HIS FULL BODY. THE PATIENT IS STILL EXPERIENCING THE RASH AND ITCHING AFTER CONSULTING WITH RHEUMATOLOGIST, IMMUNOLOGIST, GASTROENTEROLOGIST, GENERAL MEDICINE, AT VARIOUS HOSPITALS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 7 X 45MM,TI. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10820290 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE SURGICAL (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2019. AFTER 10 DAYS PATIENT DEVELOPED RASHES AND ITCHING ON HIS FULL BODY. EVEN AFTER CONSULTING SPECIALIST LIKE RHEUMATOLOGIST, IMMUNOLOGIST, GASTROENTEROLOGIST, GENERAL MEDICINE, AT VARIOUS HOSPITALS, PATIENT IS STILL SUFFERING THE SAME. AT PRESENT, THE PATIENT WANTS TO CONFIRM WITH THE COMPANY THAT IT IS NOT BECAUSE OF THE MATERIALS IMPLANTED. CURRENTLY THERE IS NO PLAN FOR ANY REVISION SURGERY. NO FURTHER INFORMATION PROVIDED THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 7X45MM,TI. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4) AND (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10819523 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE SURGICAL (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2019. AFTER 10 DAYS PATIENT DEVELOPED RASHES AND ITCHING ON HIS FULL BODY. EVEN AFTER CONSULTING SPECIALIST LIKE RHEUMATOLOGIST, IMMUNOLOGIST, GASTROENTEROLOGIST, GENERAL MEDICINE, AT VARIOUS HOSPITALS, PATIENT IS STILL SUFFERING THE SAME. AT PRESENT, THE PATIENT WANTS TO CONFIRM WITH THE COMPANY THAT IT IS NOT BECAUSE OF THE MATERIALS IMPLANTED. CURRENTLY THERE IS NO PLAN FOR ANY REVISION SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 7X45MM,TI. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4) AND (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10819514 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE SURGICAL (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2019. AFTER 10 DAYS PATIENT DEVELOPED RASHES AND ITCHING ON HIS FULL BODY. EVEN AFTER CONSULTING SPECIALIST LIKE RHEUMATOLOGIST, IMMUNOLOGIST, GASTROENTEROLOGIST, GENERAL MEDICINE, AT VARIOUS HOSPITALS, PATIENT IS STILL SUFFERING THE SAME. AT PRESENT, THE PATIENT WANTS TO CONFIRM WITH THE COMPANY THAT IT IS NOT BECAUSE OF THE MATERIALS IMPLANTED. CURRENTLY THERE IS NO PLAN FOR ANY REVISION SURGERY. NO FURTHER INFORMATION PROVIDED THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 7X45MM,TI. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4) AND (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10819500 ↗