XLIF 6910220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517390196), received between Aug 12, 2020 and Sep 22, 2025 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2025Human-Device Interface Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE USING A XLIF COBB THE INSTRUMENT SLIPPED AND NICKED AN ARTERY CAUSING BLEEDING THAT THERE WAS INTERVENTION TO ADDRESS. THE SURGEON ARRESTED BLEEDING BY PACKING AND HEMOSTATIC AGENT.ON (b)(6) 2025 THE SURGEON CONFIRMED WITH A CT SCAN THAT THERE WERE NO HEMATOMA OR OTHER ABNORMALITIES. NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23116236 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL VERTEBRAL BODY REPLACEMENT PROCEDURE OF THE L4 VERTEBRAE VIA AN OPEN APPROACH. DURING THE PROCEDURE, IT WAS NOTED THAT BLEEDING FROM THE SEGMENTAL ARTERY BEGAN DURING USE OF THE COBB NEAR THE L4/5 SPACE. HEMOSTASIS WAS APPLIED AND THE PROCEDURE WAS ABORTED. THE APPROXIMATE BLOOD LOSS WAS DETERMINED TO BE 160CC. AN ADDITIONAL PROCEDURE WAS SCHEDULED TO COMPLETE IMPLANTATION OF THE VERTEBRAL BODY REPLACEMENT DEVICE AT A LATER DATE. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15033206 ↗
• InjuryAug 12, 2020Malposition of Device; Malposition of Device

  THE PATIENT UNDERWENT EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L1/3 ON (B)(6) 2020. REPORTEDLY, PATIENTS SEGMENTAL ARTERY WAS DAMAGED WHILE THE PHYSICIAN WAS DISSECTING INTERVERTEBRAL DISC WITH A COBB AT L2/3 LEVELS. PRESSURE HEMOSTASIS WAS CONDUCTED TO STOP BLEEDING AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR VASCULAR SURGERY TREATMENT. A SPINAL PROCEDURE HAS BEEN POSTPONED AND WILL BE PERFORMED AT A LATER DATE.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10396692 ↗