VIPER PRIME 186760440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034509396), received between Apr 20, 2018 and Apr 21, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, SURGEON WAS PERFORMING L4-S1 PERCUTANEOUS FUSION WITH VIPER PRIME. FIVE SCREWS WERE IMPLANTED AS INTENDED. WHEN IT CAME TIME TO LOCKING IN THE ROD CONNECTING THE SCREWS, HE STRUGGLED TO CAPTURE THE ROD WITH THE LOCKING CAPS DUE TO THE ROD NOT BEING SEATED LOW ENOUGH FOR THE CAPS TO CATCH ON THE THREADS OF THE PRIME SCREW EXTENDED TAB. HE BEGAN TO TRY TO FORCE THE ROD LOWER SO THAT HE COULD CAPTURE IT WITH THE LOCKING CAPS, BUT HE COULD NOT GET IT LOW ENOUGH TO THE CAP TO CATCH. DURING THIS STRUGGLE, ONE OF THE EXTENDED TABS BROKE OFF MAKING IT EVEN MORE DIFFICULT TO BE ABLE TO CAPTURE THE ROD. THE BROKEN TAB WAS REMOVED WITHOUT INCIDENT. HE CONTINUED TO TRY BUT COULDN¿T GET THE ROD LOW ENOUGH TO ENGAGE MULTIPLE LOCKING CAPS ON EITHER SIDE. SO, THE SURGEON ENDED UP HAVING TO REMOVE ALL 5 SCREWS AND REPLACE THEM WITH ANOTHER SYSTEM. THE BROKEN EXTENDED TAB CERTAINLY CONTRIBUTED TO THE FRUSTRATION AND THE DECISION TO ABANDON THE SYSTEM FOR THIS PATIENT. THE SURGEON REASONED THAT IF HE CAN¿T PUT MORE FORCE ON THE ROD TO BE ABLE TO CAPTURE IT WITHOUT BREAKING THE TABS, OR IF THERE IS NOT ANOTHER REDUCTION TOOL AVAILABLE FOR VIPER PRIME, THEN HE CAN¿T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703737 ↗
• InjuryApr 20, 2018Break; Break

  VIPER PRIME CORTICAL FIX SCREW DISASSEMBLED AND PREVENTED ROD FROM REDUCING. THIS REQUIRED REMOVAL OF ROD AND 2 ADDITIONAL SCREWS TO CORRECT THE ISSUE. NEW SCREWS WERE USED. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION: ADDITIONAL INCISION SIZE WAS NEEDED AND APPROXIMATELY 45 MIN WAS ADDED TO PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. ADDITIONAL CLARIFICATION FROM SALES REP: THE INTERNAL MECHANISM OF THE POLY FEATURE WAS NO LONGER WHERE IT WAS SUPPOSED TO BE. THE OTHER SCREW HAD PART OF THE THREAD SHEAR OFF PREVENTING A SET SCREW FROM ENGAGING. THIS WAS NOTICED AFTER ROD REMOVAL AND ATTEMPTS TO REPLACE SET SCREW WERE UNSUCCESSFUL.

  Patient problems: Not Applicable

  MAUDE report 7448282 ↗