VIPER 286705200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034213668), received between Feb 14, 2018 and Jan 8, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 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: FAILURE TO REACH THERAPEUTIC GOALS, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.37MM THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18465678 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: INSTABILITY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER ,MOSS MIAMI SI /OTHER, VIPER CFX FENESTRATED AND VIPER INSTRUMENTS PRODUCTS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18464931 ↗
• InjuryJan 8, 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: FRACTURE VERTEBRAL STRUCTURES, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. INTRAOPERATIVE, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM, VIPER /OTHER, VIPER CFX FENESTRATED AND VIPER INSTRUMENTS PRODUCTS. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 18464070 ↗
• 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, IMPLANT MALPOSITION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.37MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18463495 ↗
• MalfunctionDec 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS TAPPING TOUGH SCLEROTIC BONE OVER THE GUIDEWIRE. BOTH VERSE CANNULATED TAPS SNAPPED WHEN PREPARING THE PILOT HOLE. FRAGMENTS WERE GENERATED AND REMOVED USING DOLPHIN NOSED PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE TAP. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.37MM. THIS IS REPORT 3 OF 3 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010501 ↗
• MalfunctionJul 17, 2018Break; Break

  THE ILLEUM SCREW INNER PART BROKE AND ALSO THE K WIRE UNFORTUNATELY BROKE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694968 ↗
• MalfunctionFeb 14, 2018Break; Break

  IT WAS REPORTED SURGEON WAS PLACING SCREW OVER GUIDEWIRE. UPON REMOVING GUIDEWIRE, THE TIP OF THE GUIDEWIRE BROKE OFF INTO THE VERTEBRAL BODY. ADDITIONAL INFORMATION RECEIVED 13FEB2018: THE TIP WAS NOT ABLE TO BE RETRIEVED.

  Patient problems: Local Reaction; Not Applicable

  MAUDE report 7270867 ↗