4WEB Medical ASCR-5023-T25-SPRecalls & reported problems
4web Medical · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810074753401), received between Jan 16, 2024 and Jan 16, 2024 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO 4WEB THAT A REVISION SURGERY WAS REQUIRED DUE TO NON-UNION OF TWO ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE CAGES. THE REPORT WAS SUBMITTED ABOUT NINE MONTHS POST INITIAL SUGERY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. THE TWO SCREWS USED DURING SURGERY ARE BEING REPORTED IN THIS SUBMISSION. REPORT THREE OF THREE.
Patient problems: Insufficient Information
MAUDE report 18522427 ↗InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO 4WEB THAT A REVISION SURGERY WAS REQUIRED DUE TO NON-UNION OF (B)(4) ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE CAGES. THE REPORT WAS SUBMITTED ABOUT NINE MONTHS POST INITIAL SUGERY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. THE (B)(4) SCREWS USED DURING SURGERY ARE BEING REPORTED IN THIS SUBMISSION. REPORT TWO OF THREE.
Patient problems: Insufficient Information
MAUDE report 18522422 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices
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- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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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