OptiMesh 1500 E 10-10-04-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M7403302505), received between Aug 24, 2017 and Nov 6, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2018Stretched; Stretched

  DURING PLACEMENT OF THE IMPLANT AND GRAFT FOR A LUMBAR INTERBODY FUSION PROCEDURE, A PORTION OF THE DEVICE WAS FILLED INTO THE SPINAL CANAL, RESULTING IN CAUDA EQUINA SYNDROME. PATIENT WAS RETURNED TO SURGERY DUE TO POSTOPERATIVE SYMPTOMS. THE SURGEON REPORTED THAT THE DEVICE WAS FOUND INTACT BUT PROTRUDING IN THE CANAL. IT WAS REMOVED AND REPLACED WITH AN INTERBODY SPACER. PATIENT IS REPORTED TO HAVE IMPAIRED BLADDER CONTROL, LIMITED PLANTAR FLEXION AND DORSIFLEXION, AND LOWER EXTREMITY NUMBNESS WHICH IS GRADUALLY IMPROVING.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8043440 ↗
• InjuryOct 28, 2018Migration; Migration

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8011741 ↗
• 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 7716484 ↗
• InjuryAug 24, 2017Torn Material; Torn Material

  THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION SURGICAL PROCEDURE ON (B)(6) 2017 WITH PLACEMENT OF OPTIMESH DEVICES AT THE L4-L5 AND L5-S1 LEVELS AND PLACEMENT OF A PEDICLE SCREW SPINAL CONSTRUCT. FOLLOWING THE SURGICAL PROCEDURE, POST-OPERATIVE O-ARM IMAGING REVEALED THAT THE POSITIONING AND FILLING OF BOTH OPTIMESH DEVICES WAS ADEQUATE. THE PATIENT WAS REPORTED TO BE "DOING VERY WELL" UPON DISCHARGE FROM THE HOSPITAL. APPROXIMATELY TWO MONTHS FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT PRESENTED WITH NEW RADICULAR LEG PAIN. A CT SCAN WAS PERFORMED WHICH REVEALED THAT BONE WAS PRESENT IN THE CENTRAL CANAL, THERE WERE FRACTURES OF TRANSVERSE PROCESSES AND SPINOUS PROCESSES, AND A POSSIBLE S1 PEDICLE FRACTURE. THESE FINDINGS APPEARED TO BE CONSISTENT WITH SIGNIFICANT TRAUMA. WHEN QUESTIONED, THE PATIENT DENIED ANY TRAUMA OR DEVIATION FROM THE PHYSICIAN-PRESCRIBED POST-OPERATIVE CARE PLAN. THE CLINICIAN DID NOT CONSIDER THIS PATIENT TO BE A RELIABLE HISTORIAN. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 AT WHICH TIME A RUPTURE OF THE OPTIMESH DEVICE WAS OBSERVED. THE OPTIMESH DEVICE WAS REMOVED AND REPLACED WITH ANOTHER OPTIMESH DEVICE; HOWEVER, THERE WAS NO REVIS

  Patient problems: Pain

  MAUDE report 6818577 ↗