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EXPEDIUM 179732750Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 x 7.0 x 50mm · 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 10705034074054), received between Feb 25, 2021 and Feb 25, 2021 — 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.

  • MalfunctionFeb 25, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SI POLYAXL EXT TAB 7 X 50MM WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT PRODUCT: SI POLYAXL EXT TAB 7 X 50MM. THIS COMPLAINT INVOLVES ONE (1) SI POLYAXL EXT TAB 7 X 50MM. THIS REPORT IS1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11379517 ↗

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Sources and updates

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