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X-CORE 5962152Recalls & reported problems

Nuvasive, Inc. · X-CORE Mini Core, Ø12mm 15-20mm · Class 2 · Implant

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 00887517269393), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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

  • Failure to Advance1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 27, 2023Failure to Advance; Failure to Advance

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL CORPECTOMY PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON ATTEMPTED TO EXPAND THE VERTEBRAL BODY REPLACEMENT IMPLANT IN-SITU, IT WAS NOTED THAT THE THREAD WAS STUCK, PREVENTING THE IMPLANT FROM EXPANDING AND RESULTING IN DEFORMATION TO THE SLEEVE COMPONENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17410414 ↗

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