VIPER 186789150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034132860), received between Aug 25, 2022 and Aug 25, 2022 — classified as 2 injuries.

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. 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.

• InjuryAug 25, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO OF THE RODS IN QUESTION HAD BROKEN AT THE HEIGHT OF THE CROSS-CONNECTOR. REVISION SURGERY TO REMOVE THE BROKEN IMPLANTS WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2022. NO INFORMATION ABOUT THE OUTCOME OF THE REVISION SURGERY WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD, STRAIGHT 150MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 15292120 ↗
• InjuryAug 25, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO OF THE RODS IN QUESTION HAD BROKEN AT THE HEIGHT OF THE CROSS-CONNECTOR. REVISION SURGERY TO REMOVE THE BROKEN IMPLANTS WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2022. NO INFORMATION ABOUT THE OUTCOME OF THE REVISION SURGERY WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD, STRAIGHT 150MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 15292118 ↗

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