X-CORE 7180067Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517426543), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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.

• MalfunctionJan 30, 2024Mechanical Problem; Device Damaged by Another Device; Activation Problem; Mechanical Problem; Device Damaged by Another Device; Activation Problem

  ON (B)(6) 2023 A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE AT L1-2 ONCE BEING PLACED INTO THE DISC SPACE THE IMPLANT WAS UNABLE TO EXPAND. THE SURGEON WAS ABLE TO EXPAND THE IMPLANT OUTSIDE OF THE PATIENT WITHOUT ISSUE BUT ONCE REINSERTED INTO THE DISC SPACE, THE IMPLANT WOULD NOT EXPAND. THE INSERTER HANDLE WAS STILL ABLE TO ROTATE, HOWEVER THE IMPLANT WOULD STILL NOT EXPAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608339 ↗

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.