VIPER 186727080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034282411), received between Apr 5, 2019 and Mar 15, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 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 16, 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.

• InjuryMar 15, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPEDIUM CFX SCREW REMOVAL PROCEDURE ON (B)(6) 2022 AS EXPEDIUM CFX SCREW BROKE POSTOPERATIVELY. THE INITIAL IMPLANT DATE WAS (B)(6) 2022. PATIENT OUTCOME IS REPORTED AS GOOD. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) UNKNOWN EXPEDIUM CFX SCREW 10X80MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13765341 ↗
• InjuryMar 1, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6), 2019. ON AN UNKNOWN POSTOPERATIVE DATE THE TWO (2) PEDICLE SCREWS BROKE IN THE FIRST SACRAL VERTEBRA. THE BROKEN SCREWS WERE REMOVED AND THE REVISION SURGERY WAS PERFORMED ON (B)(6), 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 10X80 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 13638521 ↗
• InjuryMar 1, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6) 2019. ON AN UNKNOWN POSTOPERATIVE DATE THE TWO (2) PEDICLE SCREWS BROKE IN THE FIRST SACRAL VERTEBRA. THE BROKEN SCREWS WERE REMOVED AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 10X80. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 13638512 ↗
• InjuryApr 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AN UNKNOWN LOCKING CAP HAS LOOSENED POSTOPERATIVELY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8488169 ↗