VIPER 186788085Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034131825), received between Aug 19, 2021 and Jan 29, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 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 THAT THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6) 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6) 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 85MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18597335 ↗
• InjuryJan 29, 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 THAT THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6) 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6) 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED. (CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 85MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18597286 ↗
• MalfunctionJul 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. THE IMPLANT BROKE DURING BENDING PROCESS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-85MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959087 ↗
• InjuryAug 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PRIMARY POSTERIOR FUSION WAS PERFORMED. ON (B)(6) 2021 IT WAS FOUND THAT THE ROD HAD BROKEN OFF AND THE SCREW HAD LOOSENED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE BROKEN TITANIUM ROD WAS REPLACED WITH A COBALT ROD. CONCOMITANT DEVICES: UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). CONN O/O SD TOP NTCH 5.5X5.5 T (PART# 179771555, LOT# UNKNOWN, QTY TWO). THIS REPORT IS FOR A VIPER ROD. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12342002 ↗

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