Skip to content

X-CORE 7220033Recalls & reported problems

Nuvasive, Inc. · X-CORE 2 Ti Core, Ø22x24-33mm · 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 00887517434258), received between Jun 27, 2016 and Jun 27, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

Device problems

  • Device Slipped1
  • Fracture1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionJun 27, 2016Fracture; Device Slipped; Fracture; Device Slipped

    ON (B)(6) 2015, A PATIENT UNDERWENT A CORPECTOMY DURING WHICH A VERTEBRAL BODY REPLACEMENT (VBR) DEVICE WAS IMPLANTED AT THE T-12 DISC SPACE. IN ADDITION, POSTERIOR FIXATION WAS PLACED AT LEVELS T9-L4. APPROXIMATELY 1 YEAR FOLLOWING SURGERY, IT WAS NOTED THE VBR HAD REDUCED IN HEIGHT AND TWO RODS APPEARED TO BROKEN CLOSE TO THE L1 CONNECTORS. A REVISION SURGERY OCCURRED (B)(6) 2016 TO REMOVE AND REPLACE ALL THE HARDWARE. PATIENT CONDITION AND STATUS OF HEALTH PRIOR TO EVENT IS UNKNOWN. PATIENT ACTIVITY LEVEL, BONE QUALITY, AND COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS ARE UNKNOWN.

    Patient problems: No Information

    MAUDE report 5752463 ↗

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.

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

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