X-CORE 7180033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517426512), received between Aug 25, 2016 and Aug 25, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionAug 25, 2016Detachment Of Device Component; Fracture; Migration or Expulsion of Device; Detachment Of Device Component; Fracture; Migration or Expulsion of Device

  A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT SURGERY ON (B)(6) 2016. DURING A ROUTINE POST-OPERATIVE CHECK-UP RADIOGRAPHS SHOWED THAT THE X-CORE 2 TI CORE, 18 X 24-33MM REPORTEDLY HAD DISPENSED FROM THE CAGE. REMOVAL OF THE COMPLETE IMPLANT IS SCHEDULED FOR SEPTEMBER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5904074 ↗

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.