X-CORE 7110002Recalls & reported problems
Nuvasive, Inc. · X-CORE 2 Driver, Set Screw · Class 1
All models of X-CORE (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00887517420756), received between Jul 25, 2024 and Jul 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Collapse” (2 reports).
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
- Collapse2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Collapse; Collapse
ON (B)(6) 2024 A PATIENT RECEIVED VERTEBRAL BODY REPLACEMENT (VBR) IMPLANTED AT L3 WITHOUT ANY REPORTED ISSUE. ON (B)(6) 2024 THE X-CORE WAS IDENTIFIED AS COLLAPSED AND A REVISION PROCEDURE TOOK PLACE WHEREIN THE X-CORE IMPLANT WAS RE-EXPANDED AND THE LOCK SCREW WAS REPLACED. ON (B)(6) 2024 THE X-CORE WAS OBSERVED COLLAPSED A SECOND TIME AND A REVISION WAS SCHEDULED. ON (B)(6) 2024 THE X-CORE WAS EXPLANTED AND A NEW ONE X-CORE WAS PLACED AT L3. NO ADDITIONAL ISSUES REPORTED. (REPORT 2 OF 2, FOR REVISION ON (B)(6) 2024)
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832105 ↗MalfunctionJul 25, 2024Collapse; Collapse
DEVICE RETURN INFORMATION AND UPDATES LISTED ON H10.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832101 ↗
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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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