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EXPEDIUM 279792103Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM CORE INSTRUMENTS 2 OF 2 5.5 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034459875), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 7, 2022Break; Break

    IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE EXP 5.5 CORE INSTR 2 OUTER WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR AN EXPEDIUM 5.5 CORE INSTRUMENT 2 OUTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14042981 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

All TRAY, SURGICAL, INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.