OptiMesh 1500 E 10-10-04-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7403302005), received between Mar 3, 2017 and Mar 3, 2017 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2017No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2017, THE PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION WITH PLACEMENT OF A 1500E OPTIMESH IMPLANT. APPROXIMATELY 4 WEEKS FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BACK PAIN AND A FEVER. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR POSTERIOR LUMBAR EXPLORATORY SURGERY AT WHICH TIME THE PHYSICIAN IDENTIFIED AN INFECTION LOCALIZED TO THE INTERVERTEBRAL DISC SPACE. THE OPTIMESH DEVICES WAS REMOVED AND CULTURES WERE TAKEN. A NEW INTERBODY FUSION DEVICE WAS NOT PLACED. MICROBIOLOGICAL RESULTS OF THE CULTURE IDENTIFIED AN ANEROBIC INFECTION CONSISTENT WITH ANAEROBES COMMONLY FOUND IN MUCOSAL MEMBRANES. AT AN UNSPECIFIED TIME FOLLOWING THE RE-OPERATION PROCEDURE, THE PATIENT WAS AGAIN RETURNED TO THE OPERATING ROOM FOR ANTERIOR LUMBAR PLACEMENT OF ANOTHER MANUFACTURER'S INTERBODY FUSION DEVICE.

  Patient problems: Fever; Pain

  MAUDE report 6377254 ↗