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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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