RADIUS 486619250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327276305), received between May 17, 2016 and Sep 20, 2016 — 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 16, 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.

• MalfunctionSep 20, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING SURGERY, THE TIP OF THE 2 DRIVERS BROKE WHEN THE SURGEON USED THEM TO FASTEN THE 20MM CROSS CONNECTOR. FINALLY, THE SURGEON DID NOT USED THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5964935 ↗
• MalfunctionSep 20, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING SURGERY, THE TIP OF THE 2 DRIVERS BROKE WHEN THE SURGEON USED THEM TO FASTEN THE 20MM CROSS CONNECTOR. FINALLY, THE SURGEON DID NOT USED THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5964926 ↗
• MalfunctionMay 17, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON USED PLUG DRIVER IN ORDER TO TIGHTEN PLUG OF THE CONNECTOR. WHEN THE SURGEON TIGHTENED THE PLUG, THE TIP OF PLUG DRIVER BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5661426 ↗