VIPER 186788040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034238210), received between May 21, 2021 and Jan 8, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 6 most recent of 6 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: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER PRIME NAVIGATION INSTRUMENT, VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 2 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18463477 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: NEUROCOMPRESSION, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 X 40MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nerve Damage; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18456570 ↗
• InjurySep 12, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON MAY 19, 2022, THE SURGEON REPORTED ABOUT THE ROD LOOSENING EXPEDIUM VERSE. IT WAS A RESTORATION OF NON-SPECIFIC CAUSE IN TWO PATIENTS. REVISION AND CONFIRMATION OF COLI INFECTION. THIS EXPLAINS THE SITUATION OF NON-FUSION AND ROD LOOSENING ACCORDING TO THE SURGEON. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-40MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15403446 ↗
• InjuryMar 8, 2022Adverse 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, CUSTOMER CONTACTED J&J FOR MATERIAL COMPOSITION OF MATRIX & T-PAL SPINAL SYSTEM BECAUSE SHE EXPERIENCES HIGH LEVELS OF PAIN IN HER BACK SINCE SHE RECEIVED THE IMPLANTS. ALSO, HIGH LEVELS OF MERCURY WAS REPORTED IN HER BLOOD. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-40MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 13689318 ↗
• InjuryMar 8, 2022Adverse 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, CUSTOMER CONTACTED J&J FOR MATERIAL COMPOSITION OF MATRIX & T-PAL SPINAL SYSTEM BECAUSE SHE EXPERIENCES HIGH LEVELS OF PAIN IN HER BACK SINCE SHE RECEIVED THE IMPLANTS. ALSO, HIGH LEVELS OF MERCURY WAS REPORTED IN HER BLOOD. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-40MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 13689251 ↗
• MalfunctionMay 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11865727 ↗