EXPEDIUM 299704170Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034467207), received between Nov 26, 2019 and Dec 14, 2023 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 14, 2023Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING THE FRENCH BENDER TO BEND THE 120MM STRAIGHT TI ROD. DURING THIS PROCESS, THE BENDER SNAPPED INTO TWO PIECES AT THE TOP OF ONE OF THE HANDLES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A SURGICAL DELAY OF 4 MINUTES. A REPLACEMENT FRENCH BENDER WAS USED. THERE WERE NO FRAGMENTS GENERATED AND NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM FRENCH ROD BENDER. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329122 ↗
• MalfunctionNov 26, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE ROUND FRENCH BENDER (EXPEDIUM VERSE) RIVET-WASHER ON THE BACK OF THE OF THE INSTRUMENT CAME AWAY AND THE INSTRUMENT CAME APART. INSTRUMENT HAD ALREADY BEEN USED WHEN THE RIVET-WASHER WAS FOUND SEPARATELY IN THE SURGICAL FIELD. THE INSTRUMENT HAD BEEN USED CORRECTLY BY THE SURGICAL TEAM AND WAS NOT OTHERWISE DAMAGED OR WORN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378576 ↗