NA 1896-4050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540202420), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED (B)(6) PERFORMED SURGERY FOR HUMERAL DIAPHYSIS FRACTURE. FINISHED WITH FIXATION OF 2 PROXIMALLY SCREWS WITH OBLIQUE AND 2 DISTALLY SCREWS WITH AP. (B)(6) PATIENT VISITED THE CLINIC. PATIENT WAS GIVEN PAINKILLERS FOR PAIN. NO X-RAYS WERE TAKEN. (B)(6) X-RAYS SHOWED GOOD BONE FUSION PROCESS, BUT IT WAS FOUND THAT 2 PROXIMAL OBLIQUE SCREWS ARE BROKEN. REVISION SURGERY FOR EXPLANT IS SCHEDULED ON (B)(6).

  Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain

  MAUDE report 19637939 ↗