NA 55-06704Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540365941), received between Dec 3, 2020 and Dec 5, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryDec 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PLATE HAD BROKEN POST-OPERATIVELY, AND A REVISION SURGERY WAS PERFORMED TO RE-PLATE THE FRACTURE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950882 ↗
• InjuryDec 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PLATE HAD BROKEN POST-OPERATIVELY, AND A REVISION SURGERY WAS PERFORMED TO RE-PLATE THE FRACTURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950851 ↗
• InjuryDec 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PLATE HAD BROKEN POST-OPERATIVELY, AND A REVISION SURGERY WAS PERFORMED TO RE-PLATE THE FRACTURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938338 ↗