OptiMesh Multiplanar Expandable Interbody Fusion System 102-47-01Recalls & reported problems
Spineology Inc. · 4.75mm Rod Hand Brace · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7401001285), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE ON (B)(6) 2025. DURING THE SURGICAL PROCEDURE WHILE FILLING THE MESH IMPLANT, IMAGING CONFIRMED PORTAL TUBE ADVANCEMENT ANTERIORLY THROUGH THE ANNULUS. THE PORTAL TUBE WAS RETRACTED AND THE MESH IMPLANT COMPONENT REMOVED. THE SURGEON CONFIRMED NO PATIENT INJURY OR CONSEQUENCE AS A RESULT OF THE ANNULUS BREACH. AN ALTERNATE INTERVERTEBRAL FUSION DEVICE AND FIXATION WERE PLACED TO COMPLETE THE SURGICAL PROCEDURE WITHOUT PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699756 ↗
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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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