EXPEDIUM 286240040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034341859), received between Mar 2, 2022 and Mar 2, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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.

• MalfunctionMar 2, 2022Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENTS ARE WORN AND SLIPPED OFF THE ROD. THE SURGEON USED DIFFERENT BENDING TOOLS TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM ROD BENDER, IN-SITU. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654653 ↗
• MalfunctionMar 2, 2022Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENTS ARE WORN AND SLIPPED OFF THE ROD. THE SURGEON USED DIFFERENT BENDING TOOLS TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM ROD BENDER, IN-SITU. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654580 ↗