X-CORE 7180027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517426505), received between Jan 18, 2016 and Jan 18, 2016 — classified as 1 injury.

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.

• InjuryJan 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 A FEMALE PATIENT UNDER WENT AN XLIF PROCEDURE FOR CORPECTOMY AT L1. AFTER PLACING THE XCORE II THE SURGEON WAS REMOVING THE POSTERIOR VERTEBRAL WALL WHEN THE CHISEL ACCIDENTLY ENTERED THE SPINAL CANAL AND SPINAL FLUID LEAKED. MEP AMPLITUDE DECREASED BUT WAVEFORM WAS DISPLAYED UNTIL CLOSURE OF THE INCISIONS. FOLLOWING CORPECTOMY, POSTERIOR DECOMPRESSION AND SPINAL CORD REPAIR WAS PERFORMED. DURING FOLLOW-UP THE PATIENT REPORTEDLY DEVELOPED PARALYSIS OF THE LOWER EXTREMITIES.

  Patient problems: Spinal Column Injury

  MAUDE report 5375640 ↗

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.