EXPEDIUM VERSE 199723635SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034443485), received between Nov 19, 2021 and Nov 19, 2021 — classified as 2 injuries.

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 16, 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.

• InjuryNov 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREWS RUPTURED POSTOPERATIVELY AT S1 LEVEL. THE PATIENT EXPERIENCED THE PAIN. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021. THE BROKEN SCREWS WERE REMOVED ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0 X 35. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12846507 ↗
• InjuryNov 19, 2021Break; Break

  UPDATED EVENT DESCRIPTION. CONCOMITANT DEVICE REPORTED. UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Pain

  MAUDE report 12846497 ↗