4WEB Medical ASTS-SA-100006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812998043903), received between Sep 21, 2021 and Aug 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED TO THE MANUFACTURER THAT TIP OF AN AWL BROKE DURING SURGERY AND WAS LEFT IN THE PATIENT. NO INJURY TO PATIENT WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018731 ↗
• MalfunctionApr 17, 2024Break; Break

  THE TIP OF THE STRAIGHT PUNCH AWL USED IN SURGERY BROKE WHEN SURGEON REMOVED THE AWL FROM THE CAGE. TIP OF AWL REMAINS IN PATIENT WITHIN THE INTEGRATED 4WEB CAGE. NO INJURY TO PATIENT WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129344 ↗
• MalfunctionSep 21, 2021Break; Break

  THE TIP OF THE STRAIGHT PUNCH AWL USED IN SURGERY BROKE IN THE SCREW HOLE OF THE 4WEB ANTERIOR CAGE. IT WAS REPORTED THAT THE ANTI-BACKOUT PLATE WAS ENGAGED, HOWEVER, DUE TO THE TIP BREAKING, ONE OF THE THREE SCREWS COULD NOT BE IMPLANTED WITH THE CAGE. THE TIP OF THE INSTRUMENT WAS LEFT IN THE PATIENT SINCE IT COULD NOT BE RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510015 ↗