4WEB Medical PSTS-SM0612-26-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 00812998022540), received between Apr 4, 2019 and Jun 24, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN APPROXIMATELY ONE YEAR POST-OP. A REVISION SURGERY WAS PERFORMED WHICH RESULTED IN REPLACEMENT OF PEDICLE SCREWS. 4WEB IMPLANT WAS NOT REPOSITIONED OR EXPLANTED.
Patient problems: Pain
MAUDE report 8727858 ↗InjuryApr 4, 2019Migration; Migration
IT WAS REPORTED THAT DURING THE PATIENT'S FOLLOW-UP APPOINTMENT IT WAS FOUND THAT THE IMPLANT MIGRATED POSTERIORLY AND WAS CAUSING THE PATIENT PAIN. THE COMPANY WAS NOTIFIED THAT THE PATIENT REQUIRED A REVISION SURGERY. NO COMPLICATIONS WERE REPORTED TO THE MANUFACTURER. THE PATIENT IS DOING WELL POST-OPERATIVELY.
Patient problems: Pain
MAUDE report 8483187 ↗
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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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