VIPER 186788075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034131801), received between Jan 9, 2024 and Jan 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2024Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 AN EXTENSION PROCEDURE (SPINAL FUSION) PERFORMED. THE PATIENT WHO HAD AN L4-5 FUSION ON (B)(6) 2021 UNDERWENT THE EXTENSION PROCEDURE UP TO S1, THE ROD IN QUESTION WAS USED. AFTER STANDARD SPINAL FUSION TREATMENT AND ROD MEASUREMENT, A NURSE OBSERVED ADHESIONS ON THE ROD. ALTHOUGH THE PRODUCT HAD NOT YET BEEN USED ON THE PATIENT, IT WAS DISCARDED BECAUSE IT ALREADY HAD PATIENT BLOOD ON IT. A SPARE PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD, PRE-LORDOSED 75MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18606854 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED AN UNKNOWN SPINE SURGERY OCCURRED ON (B)(6) 2018. POST OPERATIVELY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE PLAN IS TLIF FOR L2/3, AND L5 MIGHT BE REMOVED DEPENDING ON INTRAOPERATIVE DECISION. NO FURTHER INFORMATION IS AVAILABLE. (B)(4). THIS REPORT IS FOR ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 75MM FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18475605 ↗

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