VIPER PRIME 186745445SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034529844), received between May 12, 2023 and Jun 12, 2025 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PPS WAS PERFORMED WITH VIPER PRIME SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, IT WAS CONFIRMED THAT TWO OF THE FOUR VIPER PRIME SCREWS HAD BROKEN WITHIN THE PATIENT. THE PATIENT WAS NOT AFFECTED AND NO REOPERATION IS PLANNED. PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22194750 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PPS WAS PERFORMED WITH VIPER PRIME SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, IT WAS CONFIRMED THAT TWO OF THE FOUR VIPER PRIME SCREWS HAD BROKEN WITHIN THE PATIENT. THE PATIENT WAS NOT AFFECTED AND NO REOPERATION IS PLANNED. PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22194749 ↗
• InjuryMay 12, 2023Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIAL PROCEDURE WAS A PSF (T12/L1) FOR OSTEOPOROTIC VERTEBRAL FRACTURE PERFORMED ON (B)(6) 2023. AFTER SURGERY, THE SCREWS IN QUESTION WERE FOUND TO BE COMING OFF AND TOUCHING SKIN. IT WAS ALSO FOUND THAT THE SCREWS HAD NOT BEEN INSERTED INTO PROPER PLACES I.E., NOT INSERTED INTO PEDICLES IN THE PRIMARY SURGERY. ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, TH12/L1 LEFT SCREWS WERE REPLACED. RODS WERE BENT TO PREVENT INSERTING SET SCREWS TO BE INSERTED FORCIBLY, AND THE SURGEON COMPLETED FINAL TIGHTENING. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 4.5X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16922095 ↗
• InjuryMay 12, 2023Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT INITIAL PROCEDURE WAS A PSF (T12/L1) FOR OSTEOPOROTIC VERTEBRAL FRACTURE PERFORMED ON (B)(6) 2023. AFTER SURGERY, THE SCREWS IN QUESTION WERE FOUND TO BE COMING OFF AND TOUCHING SKIN. IT WAS ALSO FOUND THAT THE SCREWS HAD NOT BEEN INSERTED INTO PROPER PLACES I.E., NOT INSERTED INTO PEDICLES IN THE PRIMARY SURGERY. ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, TH12/L1 LEFT SCREWS WERE REPLACED. RODS WERE BENT TO PREVENT INSERTING SET SCREWS TO BE INSERTED FORCIBLY, AND THE SURGEON COMPLETED FINAL TIGHTENING. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 4.5X45. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16922035 ↗