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EXPEDIUM 279763850Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM CORONAL L-BENDERS LEFT 6.35 · Class 1

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 10705034201092), received between Jun 24, 2020 and Jun 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionJun 24, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THE EXPEDIUM 6.35 INSITU BENDERS WERE DEFORMED WHILE BENDING A ROD. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) CORONAL L-BENDER (L). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10188661 ↗

Other BENDER devices

All BENDER devices →

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