NA 238.28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982161697), received between Dec 10, 2021 and Dec 10, 2021 — 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 16, 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.

• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY FOR A SUBTROCHANTERIC FRACTURE. A 130-DEGREE ANGLED BLADE PLATE WAS IMPLANTED DURING THE SURGERY. AT SOME POINT BEFORE THE ALERT DATE, THE PLATE BROKE. THE SURGERY TO REMOVE THE BROKEN PLATE TOOK PLACE ON (B)(6) 2021. THERE WAS A NON-UNION AND PLATE BREAKAGE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 130 DEG ANGLED BLADE PL 12 HOLES/90/200. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12977826 ↗