VIPER 186788070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034131795), received between Nov 10, 2020 and Jul 10, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782193 ↗
• MalfunctionJun 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY, WHEN THE ROD 70 MM WAS BENT, IT WAS NOT POSSIBLE TO MOUNT ON THE HOLDER. IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD, PRE-LORDOSED 70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467768 ↗
• 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: WOUND INFECTION DEEP, POSTOPERATIVE INFECTION DEEP, POSTOPERATIVE INFECTION SUPERFICIAL COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (VIPER2 LORDOTIC ROD-70MM (B)(4).

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18463235 ↗
• 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: WOUND INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 18449615 ↗
• 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) VIPER2 LORDOTIC ROD-70MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10820429 ↗
• 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) VIPER2 LORDOTIC ROD-70MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10819791 ↗

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