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Monolith 5991417Recalls & reported problems

Nuvasive, Inc. · Monolith Core, Ø14x17mm · 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 00887517677167), received between Nov 15, 2017 and Nov 15, 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

  • Fluid Discharge1
  • Pain1
  • Post Operative Wound Infection1

Recent adverse event reports

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

  • InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017, A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY C3-C4, C4-C5 LEVELS AND CORPECTOMY OF C4 WITH INSERTION OF MONOLITH CAGE. NO COMPLICATIONS WERE REPORTED DURING SURGERY. ON (B)(6) 2017, PATIENT DEVELOPED MALAISE AND BEGAN DRAINAGE FROM NECK. PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2017 WITH DIAGNOSIS OF WOUND SEROMA. PATIENT WAS TAKEN TO THE OR AND PRIOR INCISION WAS OPENED. PULSE LAVAGE WITH 4 LITERS OF NORMAL SALINE AND DEBRIDEMENT OF WOUND. THE DEEP DRAIN WAS REPLACED.

    Patient problems: Fluid Discharge; Pain; Post Operative Wound Infection

    MAUDE report 7033142 ↗

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