VIPER PRIME 186770240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034509464), received between Dec 21, 2020 and Nov 30, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 18, 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.

• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON ((B)(6) 2023. AN IMPLANT REMOVAL AND REVISION WAS SCHEDULED FOR (B)(6) 2023 BECAUSE THE L4 PEDICLE SCREWS FAILED WITH SUBSIDENCE INTO L4 WITH XPAC CAGE. THIS REPORT INVOLVES ONEVIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18238457 ↗
• InjuryNov 6, 2023Migration; Migration

  THIS REPORT INVOLVES ONE VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18072401 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ISSUES RELATED TO A PREVIOUS FUSION DONE AT (B)(6) ON (B)(6) 2020 AND ALL THE HARDWARE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS AN L4-5 RIGHT SIDED TLIF WITH VIPER PRIME AND CONDUIT PLIF CULTURES WERE TAKEN INTRA-OP FOR A SUSPECTED FUNGAL INFECTION. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME X-TAB, 7X45MM TI. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11049190 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE PATIENT EXPERIENCED POST-OP ISSUES AFTER A PROCEDURE FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L4-5 RIGHT SIDE. THE INITIAL PROCEDURE FOR TLIF WAS PERFORMED ON (B)(6) 2020 WITH THE VIPER PRIME AND CONDUIT PLIF. ON (B)(6) 2020 THE HARDWARE WAS REMOVED, AND CULTURES WERE TAKEN FOR SUSPECTED FUNGAL INFECTION. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11046884 ↗