Skip to content

X-CORE 7160022P2Recalls & reported problems

Nuvasive, Inc. · X-CORE 2 Ti Core, Ø16mm 16-22mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517684936), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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

Device problems

  • Physical Resistance/Sticking1
  • Premature Activation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 30, 2023Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

    ON (B)(6) 2023 A PATIENT UNDERWENT A VERTEBRAL BODY REPLACEMENT PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE A VERTEBRAL REPLACEMENT IMPLANT WAS PLACED AND DISTRACTED. THE SURGEON THEN REMOVED THE DISTRACTED IMPLANT AND REPOSITIONED IT BUT NOW IT FAILED TO DISTRACT. ANOTHER LARGER IMPLANT WAS IMPLANTED AND IT TOO FAILED TO DISTRACT. A THIRD EVEN LARGER IMPLANT WAS UTILIZED WITHOUT ISSUE. THERE WERE NO ADVERSE COMPLICATIONS TO THE PATIENT AS A CONSEQUENCE OF THE DEVICE FAILURES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17651995 ↗

Other Spinal vertebral body replacement device - Cervical devices

All Spinal vertebral body replacement device - Cervical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.