OptiMesh 1500 E 10-10-04-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M7403302705), received between Jul 24, 2018 and Oct 28, 2018 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 28, 2018Appropriate Device Problem Term/Code Not Available

  PATIENT AWOKE WITH NEW LEG PAIN FOLLOWING LUMBAR FUSION SURGERY. A FOLLOW-UP CT IDENTIFIED BONE GRAFT IN THE CENTRAL CANAL AT L3-L4. A SECOND SURGERY WAS PERFORMED TWO DAYS LATER. A LAMINECTOMY WAS PERFORMED AT L2-L3 AND BONE GRAFT WAS REMOVED FROM THE CANAL AT L2-L3 AND AT L3-L4, AND INTRAOPERATIVE NEUROMONITORING SHOWED IMMEDIATE IMPROVEMENT. THE IMPLANT AND A LARGE PIECE OF DISC MATERIAL WERE BOTH REMOVED FROM THE L3-L4 DISC SPACE AND REPLACED WITH AN EXPANDABLE FUSION CAGE AND ALLOGRAFT. THE SYMPTOMS ARE REPORTED TO BE RESOLVED.

  Patient problems: Pain

  MAUDE report 8012455 ↗
• InjuryJul 24, 2018Migration; Migration

  PATIENT UNDERWENT AN INSTRUMENTED 3-LEVEL LUMBAR INTERBODY FUSION PROCEDURE AT L2-3, L3-4 AND L4-5. PATIENT AWOKE POST-OP WITH BILATERAL NUMBNESS IN LOWER EXTREMITIES. IMMEDIATE CT SHOWED MIGRATION OF GRAFT/IMPLANT AT L2-3 AND L4-5, WITH ALLOGRAFT BONE IN CENTRAL CANAL. IT WAS NOTED THAT ROD REDUCTION CAUSED STRAIGHTENING OF THE CURVED RODS, INDICATING SIGNIFICANT MECHANICAL FORCE HAD BEEN APPLIED. PATIENT WAS RETURNED TO THE OR FOR DECOMPRESSION OF THE CENTRAL CANAL AND REMOVAL OF INTERBODY IMPLANTS AT L2-3 AND L4-5. ALLOGRAFT BONE WAS PLACED IN THE DISC SPACES AT THOSE LEVELS AND ADDITIONAL DORSAL GRAFTING WAS PERFORMED. PATIENT WAS DISCHARGED ON POD #5 WITH RESIDUAL NUMBNESS IN BOTH LOWER EXTREMITIES AND IS RECEIVING PHYSICAL THERAPY. NUMBNESS IS REPORTED TO BE IMPROVING.

  Patient problems: Numbness

  MAUDE report 7716285 ↗