OptiMesh Expandable Interbody Fusion System 10-10-100-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M7403002628), received between Jun 21, 2023 and Jun 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Expulsion” (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.

• InjuryJun 21, 2023Expulsion; Expulsion

  THE PATIENT UNDERWENT A TWO-LEVEL INTERBODY FUSION PROCEDURE WITH PLACEMENT OF TWO OPTIMESH DEVICES WITHOUT INCIDENT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT EXPERIENCED RECURRING LEG PAIN, PROMPTING MEDICAL ATTENTION. IMAGING SHOWED OBSTRUCTION IN THE CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE BOTH IMPLANTS WITH A STATIC CAGE. THIS REPORT APPLIES TO OPTIMESH DEVICE TWO OF TWO.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17171206 ↗
• InjuryJun 21, 2023Expulsion; Expulsion

  THE PATIENT UNDERWENT A TWO-LEVEL INTERBODY FUSION PROCEDURE WITH PLACEMENT OF TWO OPTIMESH DEVICES WITHOUT INCIDENT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT EXPERIENCED RECURRING LEG PAIN, PROMPTING MEDICAL ATTENTION. IMAGING SHOWED OBSTRUCTION IN THE CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE BOTH IMPLANTS WITH A STATIC CAGE. THIS REPORT APPLIES TO OPTIMESH DEVICE ONE OF TWO.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17171205 ↗