OptiMesh Expandable Interbody Fusion System 10-10-100-2Recalls & reported problems

Spineology Inc. · OptiMesh · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7403003032), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryJul 26, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN INTERBODY FUSION DEVICE ON (B)(6) 2024. DURING THE SURGICAL PROCEDURE, THE DISTAL TIP OF A BONE FILL TUBE BENT WHEN FILLING THE IMPLANT AND COULD NOT BE EASILY REMOVED FROM THE INSERTER. UPON FORCEFUL REMOVAL, THE INSERTER ASSEMBLY WITHDREW FROM THE ACCESS TUBE SHEARING OFF THE BENT DISTAL TIP OF THE BONE FILL TUBE AND UNINTENTIONALLY RELEASING THE MESH IMPLANT. A SEPARATE INCISION AND SURGICAL APPROACH WERE NECESSARY TO REMOVE THE SHEARED TIP AND REPLACE THE PARTIALLY FILLED IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839210 ↗

Device details

UDI-DI	`M7403003032`
Brand	OptiMesh Expandable Interbody Fusion System
Model	10-10-100-2
Catalog no.	300-3032
Company	Spineology Inc.
Product code	OQB · Intervertebral Body Graft Containment Device
Class	Class 2
FDA submission	DEN200010
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 6, 2022

Device type (GMDN): Polymeric spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Other Intervertebral Body Graft Containment Device devices

OptiMesh Expandable Interbody Fusion System 10-10-100-3
Spineology Inc. · Intervertebral Body Graft Containment Device
2 reports
OptiMesh Expandable Interbody Fusion System 10-10-100-4
Spineology Inc. · Intervertebral Body Graft Containment Device
2 reports

All Intervertebral Body Graft Containment Device devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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