VIPER 186715750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034122533), received between Nov 10, 2020 and Jan 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER AND VIPER /OTHER PRODUCTS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18465363 ↗
• InjuryJan 5, 2024Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE, IMPLANT MALPOSITION, INSTABILITY, NEUROCOMPRESSION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 7X50MM,TI. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Nerve Damage

  MAUDE report 18450585 ↗
• 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 7X50MM,TI. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10820456 ↗
• 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 7X50MM,TI. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10819530 ↗