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EXPEDIUM 179722145Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 10 x 45mm · 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 10705034070155), received between Sep 5, 2018 and Sep 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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

  • Disconnection1

Patient problems

  • Not Applicable1

Recent adverse event reports

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

  • MalfunctionSep 5, 2018Disconnection; Disconnection

    ON (B)(6) 2018, THE TLIF SURGERY FOR LUMBAR SPONDYLOLISTHESIS WAS PERFORMED BY USING THE EXPEDIUM SYSTEM. THE FIXED SITE WAS L5 ¿ S1. DURING THE SURGERY, DUE TO AN EXCESSIVE INSERTING TORQUE, THE TIP OF THE DRIVER (279722400) GOT BROKEN AND THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW (EITHER 179722145 OR 179722150), WHICH RESULTED IN THE INSERTION FAILURE. THE SCREW IN QUESTION WAS EXTRACTED AND THEN A NEW SCREW WAS INSERTED. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY UNDER THE X-RAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 60-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON HAS REQUESTED US TO MAKE AN IN-DEPTH INVESTIGATION INCLUDING A POSSIBILITY OF METALLIC FATIGUE.

    Patient problems: Not Applicable

    MAUDE report 7847627 ↗

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Sources and updates

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