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EXPEDIUM 179712420Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 4.35 x 20mm · Class 2 · Implant

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 10705034067346), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

    WHILE TRYING TO REDUCE A 5.5MM INTO ROD INTO SCREW HEAD USING THE FLEX CLIP REDUCER TO SADDLE AT THE BASE OF THE SCREW BECAME DISLODGED MAKING ROD CAPTURE IMPOSSIBLE. SURGEON HAD TO REMOVE AND REPLACE THE SCREW.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7040622 ↗

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