VIPER 186731530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034351605), received between Oct 30, 2018 and Jan 11, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 30MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18494341 ↗
• MalfunctionDec 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE SURGEON REDUCING THE ROD DURING A T3-ILIUM THE TWO (2) SCREW HEAD DISASSOCIATED FROM THE SHANK. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER SYSTEM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 9412246 ↗
• MalfunctionOct 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INNER PART OF TULIP TWISTED OUT OF ALIGNMENT WHILE PLACING CORTICAL TRAJECTORY SCREWS. PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE:WERE ABLE TO USE A STAB AND GRAB DRIVER TO REMOVE SCREW AND REPLACE WITH A FRESH SCREW. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019665 ↗