EXPEDIUM 279730150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034200187), received between Sep 27, 2022 and Dec 20, 2022 — 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. 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.

• MalfunctionDec 20, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ROD HOLDER BROKE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DUAL ACTION ROD CLAMP 6.35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013279 ↗
• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SPINAL FUSION PROCEDURE, THE ROD HOLDER BROKE. THE BROKEN PIECE WAS RETRIEVED, AND A NEW ROD HOLDER WAS TAKEN OUT OF THE TRAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THE FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DUAL ACTION ROD CLAMP 6.35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493514 ↗