X-CORE 7180033ARecalls & reported problems
Nuvasive, Inc. · X-CORE 2 Ti Core, Ø18x24-33mm Autolock · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517365828), received between Sep 28, 2023 and Feb 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2019, A PATIENT UNDERWENT A CORPECTOMY PROCEDURE AT T9/11. ON (B)(6) 2024, THE PATIENT REPORTEDLY EXPERIENCED SUDDEN PAIN, RADIOGRAPHS INDICATED DISLOCATION OF ONE ENDPLATE FROM THE CORE. ON (B)(6) 2025, A REVISION TOOK PLACE INCLUDING REMOVAL AND REPLACEMENT.
Patient problems: Pain
MAUDE report 21437802 ↗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 17838543 ↗
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, ClassifiedX-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
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.