VIPER 186788035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034131726), received between Dec 19, 2019 and Jan 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); they may or may not involve this specific model.

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 4 most recent of 4 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: 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 6 OF 6 FOR COMPLAINT (B)(4)

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 18464057 ↗
• 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 MALPOSITION, KIDNEY / URINARY, COMPLICATION TIME/INTERVENTION, AND POSTOPERATIVE (BEFORE DISCHARGE). THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-35MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18460093 ↗
• InjuryJan 5, 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: CEREBRAL, WOUND INFECTION SUPERFICIAL, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE). THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-35MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT: (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18458849 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 A REVISION OF A POSTERIOR DECOMPRESSION AND FUSION (L4/5) WITH VERSE WAS PERFORMED DUE A LOSE SCREW AND PAIN. THE L4 SCREW ON THE LEFT HAD COME LOSE AND THE L5 LOCKING CAP ON THE RIGHT HAD COMPLETELY DETACHED FROM THE SCREW HEAD. THERE WAS A LOT OF METALLOSIS ON THE RIGHT SIDE. THE PATIENT WAS UPSIZED AND REVISED WITH VERSE ADVANCED EXTENDING UP A LEVEL TO L3. THIS REPORT IS FOR ONE VIPER2 LORDOSED ROD, 5.5MM X 35MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9497382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467