VIPER 186789400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034133362), received between May 7, 2015 and May 7, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2015Break

  SPINE REVISION DUE TO NON-UNION WAS PERFORMED ON (B)(6) 2015 BY (B)(6). PRIMARY PROCEDURE IN 2012 WAS A CORRECTION OF SCOLIOSIS, DONE BY THE SAME SURGEON AND AT THE SAME HOSPITAL. DURING REVISION, 2 RODS WERE REMOVED AND REPLACED. PRE-OP XRAYS ARE AVAILABLE. PATIENT INITIALS (B)(6), FEMALE, DOB (B)(6) 1942. NO FURTHER INFORMATION IS AVAILABLE. 27 APRIL 2015 UPDATE :RECEIVED MESSAGE FROM AUSTRALIA ADVISING THE FOLLOWING: I HAVE RECEIVED CONFIRMATION FROM THE REPORTER OF THIS CASE THAT THE PRODUCT DETAILS FOR THIS CASE SHOULD BE:VIPER2 STRAIGHT ROD-400MM (B)(4). THESE DETAILS ALSO MATCH THE PRODUCT THAT WAS RETURNED FOR INVESTIGATION. PLEASE BE ADVISED THAT THIS CASE HAS BEEN REPORTED TO OUR LOCAL HEALTH AUTHORITY, THE TGA. IN ORDER TO PROVIDE THE TGA WITH A COMPREHENSIVE RESPONSE, COULD YOU PLEASE ASK THE INVESTIGATORS TO PERFORM DHR AS PART OF THIS INVESTIGATION. I HAVE ADDED THE CORRECT PRODUCT DETAILS ON TO THE COMPLAINT AND REQUESTED THE INCORRECT PRODUCTS TO BE VOIDED. (B)(6).

  Patient problems: Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 4756212 ↗

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