VIPER PRIME 186770340Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034509532), received between Mar 20, 2023 and Mar 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THIS WAS A FUSION OF PELVIS FOR PELVIC FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OUT ANY SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2023, THE SURGEON SUSPECTED THAT THE SCREW IN QUESTION MIGHT BE OUT OF PROPER POSITION. ON (B)(6) 2023, IT WAS CONFIRMED THAT THE SCREW WAS OUT OF PROPER POSITION, AND A REOPERATION WAS PERFORMED ON THE SAME DAY. IN THE REOPERATION, A SCREW OF THE SAME PRODUCT CODE WAS RE-INSERTED PROPERLY, AND THE REOPERATION WAS COMPLETED SUCCESSFULLY. POSTOPERATIVE CT ALSO SHOWED NO PROBLEMS. THE SURGEON COMMENTED AS FOLLOWS; THERE WAS NO PROBLEMS IN THE SCREW OR INSTRUMENTS. THE SURGEON THOUGHT THAT THE SCREW HAD BEEN INSERTED PROPERLY AT THE TIME OF THE INITIAL SURGERY, BUT THE SCREW BECAME OUT OF POSITION BECAUSE THE PATIENT'S BONE HARDENING WAS SEVERE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16577554 ↗