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EXPEDIUM 179912640Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 6 x 40mm · Class 2 · Implant

All models of EXPEDIUM (291)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10705034086460), received between Sep 1, 2022 and Sep 1, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

  • MalfunctionSep 1, 2022Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2022 SURGEON WAS REMOVING A PEDICLE SCREW FROM A PATIENT AND THE HEAD OF THE SCREW BROKE OFF, LEAVING THE SCREW SHANK IN THE PEDICLE OF THE PATIENT. SURGEON WAS ABLE TO EVENTUALLY REMOVE THE PIECE OF THE BROKEN SCREW FROM THE PATIENT, HOWEVER IT DID REQUIRE 8-10 MINS OF ADDED TIME. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 X 6 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15337614 ↗

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Sources and updates

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