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MLX 8083424Recalls & reported problems

Nuvasive, Inc. · MLX, 8x34x24mm 8° · Class 2 · Implant

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 00887517268112), received between Mar 3, 2021 and Mar 3, 2021 — classified as 1 malfunction.

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

  • Fracture1

Patient problems

  • Blood Loss1

Recent adverse event reports

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

  • MalfunctionMar 3, 2021Fracture; Fracture

    A CAGE INTRAOPERATIVELY BROKE INSIDE A PATIENTS DISC SPACE. THE DEVICE WAS EXPLANTED BY THE SURGEON AND IN THE PROCESS THERE WAS DISRUPTION OF THE END PLATES AT THE L5 LEVEL WHICH CAUSED BLEEDING. THE BLEEDING LED TO A SINGLE UNIT BLOOD TRANSFUSION. A 2ND CAGE WAS IMPLANTED AFTER BLEEDING WAS CONTROLLED WITH NO ISSUES. PATIENT IS DOING FINE POST-OP.

    Patient problems: Blood Loss

    MAUDE report 11407610 ↗

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Sources and updates

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