VIPER PRIME 186770245Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034509471), received between Dec 6, 2017 and Feb 25, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE VIPER PRIME X-TAB, 7X45MM TI WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT PRODUCT: VIPER PRIME X-TAB, 7X45MM TI. THIS COMPLAINT INVOLVES ONE (1) VIPER PRIME X-TAB, 7X45MM TI. THIS REPORT IS1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379098 ↗
• 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 1 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11049348 ↗
• 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 2 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11049268 ↗
• MalfunctionDec 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING PROCEDURE, THE SURGEON LOADED UP A 7X45MM VIPER PRIME SCREW TO IMPLANT INTO RIGHT SIDE OF L5. WHILE EXTENDING THE STYLET THROUGH THE PEDICLE, THE STYLET BECAME BENT AND NEEDED TO BE REPLACED WITH A NEW ONE. BECAUSE THE STYLET WAS SO BENT, IT WAS VERY DIFFICULT FOR THE SURGICAL TECH TO REMOVE IT FROM THE VIPER PRIME INSERTER. WE TRIED TO BACK IT OUT FIRST BY CONNECTING A SET SCREW INSERTER TO THE STYLET DEPTH ADJUSTOR AND BACKING IT OUT BUT THE STYLET WAS TOO BENT TO BE FULLY BACKED OUT OF THE X TAB SCREW AND BECAME STUCK. WE THEN TRIED UNTHREADING THE X TAB SCREW AND ATTEMPTED TO REMOVE THE X TAB FROM THE INSERTER AND STYLET. AT THIS POINT THE SURGICAL TECH USED PLIERS ON THE SCREW HEAD AND ATTEMPTED TO PULL APART THE SCREW FROM THE INSERTER AND THE SCREW HEAD AND X-TAB SLID OFF BUT THE SCREW SHAFT REMAINED STUCK ON THE STYLET AND INSERTER. THE SURGICAL TECH THEN HAD TO USE PLIERS DIRECTLY ONTO THE SHAFT AND AT THIS POINT THE SCREW SHAFT WAS REMOVED. THE STYLET WAS STILL DIFFICULT TO REMOVE FROM THE INSERTER AND WE WERE ABLE TO GET IT OUT BY USING PLIERS TO ¿UN-BEND¿ IT. I WOULD SUGGEST INCLUDING A PROPER PROCEDURE FOR REMOVING A BENT STYLET FROM AND INSERTER IN THE TECHNIQU

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7088029 ↗