NA 55-15536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540356345), received between Jun 19, 2020 and Jan 11, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD MANDIBLE PLATES BREAK WHILE EATING. SCAN FOR REVISION SURGERY PLANNED.

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

  MAUDE report 13228272 ↗
• InjuryJun 19, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A FRACTURED JAW. POST-OPERATIVELY THE PATIENT PRESENTED WITH POSSIBLE INFECTION (PAIN, ABCESS) ON RIGHT PARASYMPHYSIS AREA. THE SURGEON REMOVED THE HARDWARE ON PARASYMPHYSIS BUT DID NOT RE-PLATE AS THE FRACTURE APPEARED HEALED. FOLLOWING THIS PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND HAD A NON-UNION AND WAS BROUGHT BACK IN FOR FIXATION OF PARASYMPHYSIS. THERE WAS NO SIGN OF INFECTION AT THE TIME OF RE-FIXATING PATIENT'S JAW. THIS RECORD PERTAINS TO THE PLATE THAT WAS IMPLANTED.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 10173956 ↗