4WEB Medical CSCR-3516-SD-SPRecalls & reported problems
4web Medical · Class 2 · Implant
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 00812998038961), received between May 26, 2026 and May 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Break
IT WAS REPORTED TO THE MANUFACTURER THAT A 4WEB CERVICAL SCREW FRACTURED DURING SURGERY. INFORMATION RECEIVED INDICATED THAT SIGNIFICANT AMOUNT OF FORCE WAS APPLIED WHILE ATTEMPTING TO FULLY SEAT THE SCREW IN ORDER TO ENGAGE THE ANTI-BACKOUT PLATE, AT WHICH POINT THE SCREW HEAD FRACTURED. THE THREADED PORTION OF THE SCREW REMAINS IMPLANTED IN THE PATIENT'S BONE. THE SECOND SCREW WAS SUBSEQUENTLY IMPLANTED WITHOUT ISSUE, AND THE ANTI-BACKOUT PLATE WAS ENGAGED. NO ADDITIONAL COMPLICATIONS OR PATIENT INJURY WERE REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Failure of Implant
MAUDE report 25291346 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
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- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
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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