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EXPEDIUM 179988435Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 6.35 x 4.35 x 35mm · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034092959), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 injury.

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

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • InjuryOct 6, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SCREW WAS BROKEN, PATIENT HAD MARFAN'S SYNDROME. THE PATIENT NEED'S A REVISION SURGERY. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 6.35 X 4.35 X 35MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12586850 ↗

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Sources and updates

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