NA 237.86SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982161567), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 injury.

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.

• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 95-DEGREE CONDYLAR PLATE AND NINE 4.5 MM CORTICAL SCREWS WERE ORIGINALLY IMPLANTED IN 2016 DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, ANTIBIOTIC BEADS WERE PLACED IN THE AREA APPROXIMATELY ONE YEAR AGO DUE TO INFECTION. PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2018 DUE TO ONGOING INFECTION. IT WAS THE PATIENT¿S DECISION TO HAVE THE HARDWARE REMOVED. THE HARDWARE WAS REMOVED FULLY INTACT. NOTHING UNTOWARD OCCURRED DURING THE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THERE IS NO EVIDENCE THAT THE EXPLANTED HARDWARE WAS RELATED TO THE ONGOING INFECTION. THE REPORTER WAS NOT AWARE OF ANY PATIENT SYMPTOMS. THIS REPORT IS FOR ONE (1) 95 DEG CONDYLAR PLATE 18 HOLES/80 MM/299 MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7433253 ↗