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DEVEX 186428010Recalls & reported problems

Medos International Sàrl · DEVEX SYSTEM WEDGED MESH 28 x 10mm, 5 DEGREES · Class 2 · Implant

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 10705034118826), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Dizziness1
  • Hypersensitivity/Allergic reaction1
  • Neurological Deficit/Dysfunction1

Recent adverse event reports

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

  • InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY.

    Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

    MAUDE report 7259339 ↗

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

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