X-CORE 7180041ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517365835), received between Jun 3, 2020 and Sep 28, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Collapse” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Mechanical Jam; Mechanical Jam

  DURING A SPINAL PROCEDURE AT LEAST ONE OF THE TWO CORES WAS DISTRACTED EX-SITU, THEN IMPLANTED AND COULD NOT BE DISTRACTED IN-SITU. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT OR CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17838598 ↗
• InjuryMar 15, 2022Collapse; Unintended Movement; Collapse; Unintended Movement

  IT WAS REPORTED THAT A FEW MONTHS AFTER THE INDEX PROCEDURE, AN X-CORE 2 VERTEBRAL BODY REPLACEMENT IMPLANT WAS FOUND TO HAVE DECREASED IN HEIGHT. THE PATIENT HAD DEVELOPED INCREASING PAIN DURING REHABILITATION AND SUBSEQUENT X-RAYS FOUND THE DECREASE IN IMPLANT HEIGHT. IT WAS REPORTED THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS AND DID NOT EXPERIENCE ANY FALLS OR OTHER TRAUMATIC EVENTS. A REVISION PROCEDURE WAS PERFORMED TO ADDRESS THE REPORTED ISSUE AND THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER X-CORE 2 DEVICE. IT WAS REPORTED THE REVISION WAS SUCCESSFUL AND THE PATIENT IS MOBILE WITH CONDITIONS SIGNIFICANTLY IMPROVED.

  Patient problems: Pain

  MAUDE report 13766267 ↗
• MalfunctionAug 18, 2020Collapse; Migration; Collapse; Migration

  SEE H10 FOR UPDATED INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 10423729 ↗
• MalfunctionJun 3, 2020Collapse; Migration; Collapse; Migration

  IT WAS REPORTED DURING AN X-RAY IT WAS IDENTIFIED THE X-CORE PRODUCT HAD COLLAPSED AND NOTED TO HAVE MIGRATED. A REVISION PROCEDURE IS SCHEDULED FOR (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10117230 ↗

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.