EXPEDIUM 279726511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034301549), received between May 27, 2021 and May 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE POST-DELIVERY CHECK OF THE INSTRUMENTS FOR PERMEABILITY, IT WAS FOUND THAT THE LOWER OPENING WAS SMALL AND IT WAS NOT POSSIBLE TO INSERT THE MINI CLEANING HANDLELET. CLEANING OF THE METAL SLEEVE WAS NOT POSSIBLE WITH THE CLEANING STYLET. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM MINI CLEANING STYLET. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893306 ↗