X-PAC EI2473LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850001720250), received between Sep 3, 2025 and Apr 1, 2026 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Collapse

  THE DEVICE WAS IMPLANTED AT L3-L4 ON (B)(6) 2025. INTRAOPERATIVE IMAGES PROVIDED BY THE SURGEON INDICATE THE CAGE WAS PARTIALLY EXPANDED AT THE TIME OF DEPLOYMENT. FOLLOW-UP IMAGING OBTAINED ON (B)(6) 2025 DEMONSTRATES A REDUCTION IN CAGE HEIGHT. THE DEVICE REMAINS IMPLANTED IN THIS CONDITION. PER THE SURGEON, THE PATIENT HAS DEMONSTRATED CONTINUED CLINICAL IMPROVEMENT AND REPORTED SATISFACTION AT FOLLOW-UP VISITS ON (B)(6) 2025 AND (B)(6) 2026. THE EVENT WAS REPORTED TO EI BY THE SURGEON DURING A ROUTINE FOLLOW-UP COMMUNICATION ON (B)(6) 2026.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 24760408 ↗
• InjurySep 3, 2025Collapse; Collapse

  EXPANDING INNOVATIONS WAS NOTIFIED THAT A 2 LEVEL TLIF PROCEDURE HAD USED A 12X32 LORDOTIC IMPLANT WHICH EXHIBITED AN INTRA-OP REDUCTION IN HEIGHT AFTER EXPANSION. THE SCRUB TECH REPORTED HAVING DIFFICULTY ASSEMBLING THE CAGE/CANNULA/INSERTER SYSTEM. THE CAGE WAS INSERTED BY THE SURGEON AND EXPANDED. INTRA-OP IMAGES TAKEN DURING THE PROCEDURE SHOWED THE REDUCTION IN EXPANSION AFTER INITIAL EXPANSION.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 22954894 ↗