X-CORE 7160063Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517424273), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

1 other recall cover devices cleared under the same FDA submission (K090176); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionMar 5, 2026Failure to Advance

  THE EXPANSION MECHANISM WITH GREEN CROWN APPEARS DAMAGED. THE INSERTER WILL NOT EXPAND IMPLANT. HAD TO SUBSTITUTE WITH DIFFERENT CAGE. THE PATIENT MAY HAVE HAD INTRA-OPERATIVE INJURY BUT NOT DIRECTLY LINKED TO LACK OF EXPANSION CAPABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523981 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090176. One submission often covers many models, so check the product and lot details in each record.

• Z-0738-2023 · Nov 10, 2022 · Open, Classified
  X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.