VIPER 286725300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034214351), received between Nov 23, 2020 and Jul 27, 2022 — classified as 3 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.

• MalfunctionJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A TLIF (L4-5-S) FOR TREATING LUMBAR SPINAL CANAL STENOSIS WITH VIPER 2 SYSTEM ON (B)(6) 2022. THE SURGEON ATTACHED AN OPEN EXTENDER TO THE SCREW FOR REDUCTION. WHEN THEY TRIED TO DEPLOY A ROD, THE L5 EXTENDER CAME OFF. THE SCREW WAS REMOVED, AND IT WAS CONFIRMED THAT THE SCREWHEAD HAD BEEN DAMAGED. THE REST OF THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS WITHOUT A FURTHER ISSUE. THIS REPORT IS FOR A VIPER2 SCREW EXTENSION, OPEN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115369 ↗
• MalfunctionDec 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CAGE BROKE DURING IMPACTION INTO HARD BONE WHERE THE SPACE WAS EXTREMELY COLLAPSED. SCREWS WERE LATER INSERTED TO BACK UP THE INTERBODY FUSION AND THE SCREWDRIVERS STRIPPED DURING FINAL TIGHTENING ATTEMPTING TO BACK OUT THE SCREWS AND ADJUST THE HEIGHT. NO FRAGMENTS WERE GENERATED. THE CAGE WILL STAY IMPLANTED. THE SURGEON PACKED THE REST OF THE SPACE WITH BONE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN INSERTION INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); COUGAR LS 18X14X50 15-DEG LORD (PART # 189150614, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM SCREW EXTENSION, OPEN. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096132 ↗
• MalfunctionNov 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2020, THE NURSE WAS TRYING TO ATTACH THE SCREW EXTENSION AND THIS SCREW EXTENSION WOULD NOT ATTACH TO THE SCREW. THE NURSE PLACED IT ASIDE AND TOOK ANOTHER SCREW EXTENSION FOR THE CASE. THEREFORE THERE WAS NO DELAY IN THE CASE AND THE PATIENT WAS NOT IMPACTED. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, OPEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886817 ↗