XLIF 6914424Recalls & reported problems
Nuvasive, Inc. · XLIF Cobb, Up Angled Large · Class 1 · Implant
All models of XLIF (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517392190), received between Jun 14, 2023 and Jan 7, 2026 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
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
- Human-Device Interface Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Great Vessel Perforation1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Human-Device Interface Problem
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
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23989287 ↗DeathJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A SPINAL PROCEDURE AT L1/5 AFTER PLACING A RETRACTOR AT L4/5, THE FIRST LEVEL OF FIXATION, THE COBB SLIPPED ANTERIORLY WHILE WORKING IN THE INTERVERTEBRAL SPACE AND INJURED THE AORTA. DUE TO EXCESSIVE BLEEDING, IMMEDIATE COMPRESSION AND HEMOSTASIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY. THE PATIENT WAS PRONOUNCED DEAD.
Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 17131550 ↗
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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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