EXPEDIUM 279712510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034198965), received between Jun 28, 2022 and Oct 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionOct 26, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE ONE OF THE TONGS THAT ATTACH TO THE SCREW ON THE ONE-HANDED REDUCTION DEVICE WAS BENT INWARD AND WOULD NOT FUNCTION PROPERLY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ONE HANDED ROD APPROXIMATOR 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674486 ↗
• MalfunctionJun 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SPRINGS OF THE REDUCER WAS BENT IN. IT WAS DISCOVERED DURING QUALITY ASSURANCE (QA) IN CPD . THE INSTRUMENT WAS REMOVED FROM THE SET. NO PATIENT CONSEQUENCES DUE TO THIS EVENT. THIS REPORT IS FOR ONE (1) ONE HANDED ROD APPROXIMATOR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843540 ↗