X-CORE 6184000Recalls & reported problems
Nuvasive, Inc. · X-CORE 2 Ti Endcap, Ø18x18x40mm 0° · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517294326), received between Aug 12, 2016 and Aug 12, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loss of or Failure to Bond1
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.
MalfunctionAug 12, 2016Loss of or Failure to Bond; Loss of or Failure to Bond
ON (B)(6) 2015, A PATIENT UNDERWENT A L1 CORPECTOMY DURING WHICH A VERTEBRAL BODY REPLACEMENT(VBR) DEVICE WAS IMPLANTED. IN ADDITION, POSTERIOR FIXATION WAS PLACED AT LEVELS T10-L4. APPROXIMATELY 16 MONTHS FOLLOWING SURGERY, IT WAS NOTED THE SET SCREWS WERE STILL INTACT; HOWEVER, THE ENDCAP HAD SEPARATED. 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 5872756 ↗
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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