X-CORE 7160035Recalls & reported problems
Nuvasive, Inc. · X-CORE 2 Ti Core, Ø16x23-35mm · Class 2 · Implant
All models of X-CORE (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517424242), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE A DEVICE WAS BEING IMPLANTED DURING A VERTEBRAL BODY REPLACEMENT SURGERY THE PATIENT DEVELOPED A SUSPECTED PNEUMOTHORAX, WHICH REQUIRED THE PLACEMENT OF A CHEST TUBE TO TREAT. NO INFORMATION WAS PROVIDED ON HOW THE PNEUMOTHORAX OCCURRED. NO INFORMATION ON THE PATIENT'S CURRENT CONDITION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 20929537 ↗
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 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · 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
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, 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 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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