X-CORE 7160025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517424235), received between Sep 1, 2021 and Dec 31, 2025 — classified as 1 injury, 2 malfunctions.

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

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPERATION ON (B)(6) 2025; FIXATION LEVEL: TH10 ¿ L3: PS, L1 :X-CORE, L2/3 PLIF. THE CONDITION WAS AN L1 BURST FRACTURE. THE SURGEON INSERTED COROENT LM INTO THE L2/L3 INTERVERTEBRAL SPACE BY PLIF AND PERFORMED POSTERIOR FIXATION FROM TH10 TO L3. AND THEN, THE SURGEON THEN CHANGED THE PATIENT'S POSITION AND REPLACED THE L1 TO X-CORE VIA AN ANTERIOR APPROACH. DURING THE SURGERY, THERE WAS MINIMAL BLEEDING AND THE PATIENT'S VITAL SIGNS WERE STABLE. HOWEVER, THE PATIENT BUT DID NOT REGAIN CONSCIOUSNESS AND EXHIBITED OCCASIONAL CONVULSIONS. CT SCANS WERE PERFORMED FROM THE HEAD (INCLUDING THE IMPLANT SITE) TO THE ABDOMEN, BUT THE SURGEON COULD NOT IDENTIFY THE CAUSE. THE PATIENT TREATED IN THE ICU WHILE THE CAUSE IS BEING INVESTIGATED. ON (B)(6), THE PATIENT HAD AN MRI SCAN TO FIND THE CAUSE, AND THERE WERE NO FINDINGS IN THE BLOOD VESSELS AND IMPLANTS. WE DID NOT OBTAIN ANY COMMENTS REGARDING A CAUSAL RELATIONSHIP WITH OUR IMPLANTS AND MEDICAL DEVICES FROM THE SURGEON. THE SURGEON SUSPECTED NEUROLOGICAL DAMAGE DUE TO AN EPILEPTIC SEIZURE, CEREBRAL INFARCTION, OR PULMONARY EMBOLISM, BUT COULD NOT IDENTIFY THE CAUSE. ON (B)(6): THE PATIENT SHOWE

  Patient problems: Insufficient Information

  MAUDE report 23933826 ↗
• MalfunctionNov 3, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING SURGERY THE X-CORE 2 FAILED TO EXPAND. THE SURGEON REMOVED IT AND IMPLANTED ANOTHER ONE. THIS EVENT OCCURRED IN ITALY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457944 ↗
• MalfunctionSep 1, 2021Migration; Migration

  ON (B)(6) 2021 A PATIENT UNDERWENT A CORPECTOMY THE FIRST OF A TWO-PART PROCEDURE AT T12. ON THE SECOND PART POSTERIOR FIXATION AT T10/L2 WAS COMPLETED. ON (B)(6) 2021 THE PATIENT REPORTED PAIN AND RADIOGRAPHS REVEALED SUBSIDENCE AT T12 AND FOUR SCREWS AT L1 AND L2 BACKED OUT. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED WHERE THE FOUR SCREWS AT L1/2 WERE REPLACED AND THE CONSTRUCT WAS EXTENDED TO T10/L4.

  Patient problems: Pain

  MAUDE report 12411339 ↗

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.