NA 232.069Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982159847), received between Nov 25, 2020 and Nov 25, 2020 — 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF PLATE AND AN UNKNOWN SCREWS FOLLOWED BY A HINDFOOT NAIL PROCEDURE DUE TO NONUNION AND A BROKEN PLATE AND ONE (1) BROKEN UNKNOWN CORTEX SCREW. INITIALLY, THE PATIENT WAS IMPLANTED WITH A CANNULATED ANGLED BLADE PLATING SYSTEM ON (B)(6) 2020. IT WAS ALSO REPORTED THAT THERE WAS DELAYED HEALING AND DECREASED RANGE OF MOTION. CONCOMITANT DEVICES REPORTED: UNKNOWN 3.5 MM CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). UNKNOWN CANCELLOUS SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 6 HOLES/45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10900980 ↗