EXPEDIUM 279787000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034202952), received between Mar 19, 2022 and Dec 2, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE WEAR RESISTANT PART ON THE RUBBER RELEASES PARTICLES THAT CAN BE HARMFUL TO THE PATIENT. THIS WAS A POST-OPERATIVE EVENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM WIRE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906510 ↗
• MalfunctionMar 19, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE CUTTING BLADES OF THE INSTRUMENT ARE DEFECTIVE. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS COMPLAINT INVOLVES ONE (1) DEVICE EXPEDIUM WIRE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825659 ↗