NA 55-15922Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540356406), received between Mar 20, 2019 and Oct 13, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PLATE WAS DISCOVERED AS BROKEN POSTOPERATIVELY AND THE SURGEON PERFORMED A REVISION SURGERY TO REPLACE THE PLATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627663 ↗
• InjuryDec 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT A RECONSTRUCTION PLATE FRACTURE WAS FOUND POST-OPERATIVELY APPROXIMATELY TWO YEARS AFTER IMPLANTATION. THE PROCEDURE INVOLVED A MODIFICATION OF PATIENT'S DENTAL JOINT WITH A LATERODEVIATION OF THE LEFT MANDIBLE, SLIGHT PAIN, ESPECIALLY IN THE RIGHT TEMPOROMANDIBULAR JOINT. THERE WAS NO REPORTED NOTION OF TRAUMA OR ORAL CLOSING FORCE.

  Patient problems: Pain

  MAUDE report 9426289 ↗
• InjuryJun 12, 2019Fracture

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2013, THE MANDIBULAR RECONSTRUCTION PLATE FRACTURED WITHOUT ANY NOTION OF TRAUMA NOR CLOSING FORCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693125 ↗
• MalfunctionMar 20, 2019Break; Fracture; Material Protrusion/Extrusion; Fracture; Material Protrusion/Extrusion

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A PATIENT'S X-RAY REVEALED A BROKEN IMPLANT PLATE. THERE IS NO INFORMATION AVAILABLE ON HOW THE PLATE BROKE OR WHETHER REVISION SURGERY IS PLANNED.

  Patient problems: Failure of Implant; No Information; Pain

  MAUDE report 8438185 ↗