VIPER PRIME 186770350SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034530192), received between Jul 31, 2020 and Aug 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Migration; Migration

  IT WAS REPORTED THAT THIS WAS A TLIF (L2-4) FOR SPINAL CANAL STENOSIS ON (B)(6) 2025, WITH VIPER PRIME SCREW. AFTER SURGERY, A CT SCAN CONFIRMED THE VIPER PRIME SCREW (L4 RIGHT) HAD BECOME DISLODGE. THEREFORE, THE SCREW WAS REPLACED ON (B)(6) 2025. SINCE THERE WAS NO SCREWDRIVER AVAILABLE TO ATTACH TO THE SCREW THAT HAD THE TAB CUT OFF, A NEW SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819414 ↗
• MalfunctionJul 11, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (L4, L5) FOR CERVICAL SPINAL CANAL STENOSIS ON (B)(6) 2024. IN THE SURGERY, AFTER THE SCREWS WERE INSERTED AND THE RODS INSTALLED, THE FRONT AND SIDES OF THE IMAGE WERE CHECKED AND THE TABS WERE FOLDED FOR THE FINAL FASTENING. WHEN THE SURGEON DID A FINAL CHECK ON THE IMAGE BEFORE CLOSING, THE SCREWS IN QUESTION HAD TO BE REINSERTED. THE LEFT SET SCREW AND THE ROD IN QUESTION WERE REMOVED, AND THE L4 AND L5 SCREWS WERE EXTRACTED AND REINSERTED. VIPER PRIME USED A NEW SCREW BECAUSE THERE IS NO SCREWDRIVER THAT CAN INSERT A SCREW WITHOUT A TAB. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720195 ↗
• MalfunctionJul 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, WHEN THE SCREW WAS INSERTED WITH A DRIVER AND A STYLET, IT BECAME IMPOSSIBLE TO DETACH THE DRIVER AND THE STYLET. DUE TO THE ROBUST BONE QUALITY, THE SCREW AND THE INSTRUMENTS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS WITH A LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THE REMOVED STYLET WAS CHECKED AND IT WAS DISCOVERED THAT THE STYLET WAS BENT. THE PATIENT WAS REPORTED AS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: INSERTION INSTRUMENTS: EIT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX XTAB 7X50MM TI. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10351211 ↗