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Monolith 5991220Recalls & reported problems

Nuvasive, Inc. · Monolith Core, Ø12x20mm · 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 00887517676931), received between Sep 1, 2017 and Sep 1, 2017 — 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

  • Nerve Damage1
  • Paralysis1

Recent adverse event reports

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

  • InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RECEIVED A VOLUNTARY EVENT REPORT (MW5071101) STATING: PATIENT UNDERWENT A SINGLE-LEVEL C6 ANTERIOR CERVICAL CORPECTOMY AND FUSION USING A MONOLITH DEVICE. PARALYSIS REPORTEDLY RESULTED FROM THE PROCEDURE. PATIENT UNDERWENT AN UNSPECIFIED REVISION PROCEDURE SIX MONTHS POST-SURGERY.

    Patient problems: Nerve Damage; Paralysis

    MAUDE report 6837753 ↗

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