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Monolith 5991425Recalls & reported problems

Nuvasive, Inc. · Monolith Core, Ø14x25mm · 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 00887517677228), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryOct 24, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017 A PATIENT UNDERWENT A VERTEBRAL BODY REPLACEMENT PROCEDURE AT L4-L5 LEVELS. DURING THE TWO WEEK FOLLOW UP RADIOGRAPHS REVEALED A GAP BETWEEN THE END CAP OF THE IMPLANT AND THE VERTEBRAL BODY. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE WHERE THE 25 MM IMPLANT WAS REPLACED WITH A 27 MM IMPLANT. NO PATIENT INJURY OR PRODUCT MALFUNCTION REPORTED.

    Patient problems: No Code Available

    MAUDE report 6974501 ↗

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