X-CORE 7160022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517424228), received between Oct 18, 2023 and Dec 4, 2024 — classified as 3 malfunctions.

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

• MalfunctionDec 4, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE THE CORE OF AN IMPLANT DID NOT EXPAND ONCE IN PLACE. THE CORE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO FURTHER CASE IMPACT AND NO IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849266 ↗
• MalfunctionMar 11, 2024Mechanical Jam; Mechanical Jam

  DURING A SPINAL PROCEDURE THE INTERBODY WAS PLACED ON L1, BUT COULD NOT BE EXPANDED. IT WAS REMOVED AND REPLACED WITH NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881867 ↗
• MalfunctionOct 18, 2023Mechanical Jam; Mechanical Jam

  SCRUB TECH BROKE EXPANSION MECHANISM IN CORE AND WILL NOT EXPAND FROM STARTING HEIGHT WHEN PLACED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17960392 ↗

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.