OptiMesh Expandable Interbody Fusion System 10-10-100-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M7403003440), received between May 17, 2024 and May 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE ON (B)(6) 2023 WITHOUT INCIDENT. DURING A POST-OPERATIVE APPOINTMENT, IMAGING SHOWED THE IMPLANT PARTIALLY OUTSIDE OF THE DISC SPACE WITH LOSS OF GRAFT CONTAINMENT. A REVISION SURGERY WAS CONDUCTED APPROXIMATELY 10 MONTHS POST-OPERATIVE TO PLACE AN ADDITIONAL SMALLER OPTIMESH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346103 ↗
• InjuryMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE ON (B)(6) 2024 WITHOUT INCIDENT. DURING A TWO (2) WEEK POST-OPERATIVE APPOINTMENT, IMAGING SHOWED THE IMPLANT PARTIALLY OUTSIDE OF THE DISC SPACE WITH LOSS OF GRAFT CONTAINMENT. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345943 ↗