X-CORE 7180055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517426536), received between Feb 22, 2017 and May 4, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2017Device Slipped; Device Slipped

  ON (B)(6) 2016 A MALE PATIENT UNDERWENT A PARTIAL VERTEBRECTOMY AND REPLACEMENT AT L2 AFTER A BURST FRACTURE WITHOUT INCIDENT. APPROXIMATELY (B)(6) 2017 FOLLOW UP RADIOGRAPHS APPEARED TO SHOW A 5 MM VBR HEIGHT LOSS. PATIENT EXPRESSED SOME INTERMITTENT PAIN IN LEFT GLUTEAL AREA. NO INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6546499 ↗
• MalfunctionFeb 22, 2017Device Slipped; Device Slipped

  A PATIENT UNDERWENT A VERTEBRAL BODY REPLACEMENT (VBR) ON (B)(6) 2014. APPROXIMATELY 26 MONTHS AFTER SURGERY, IT WAS NOTED THE VBR HAD REDUCED IN HEIGHT 5-6MM. PATIENT IS ASYMPTOMATIC. NO REVISION SURGERY IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 6349826 ↗

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.