NA 78-92004Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327370973), received between Apr 19, 2023 and Jul 16, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LAWSUIT THAT FOLLOWING BILATERAL JAW OSTEOTOMIES WITH IMPLANTATION OF FOUR ORTHOGNATHIC PLATES, THE PATIENT ALLEGEDLY SUSTAINED A LIP BURN AND PERMANENT CHEEK SCARRING. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED TO REMOVE REPORTEDLY MISALIGNED PLATES AND REPAIR THE MANDIBLE.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 25839630 ↗
• InjuryMay 28, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DISCREPANCIES CAUSED INACCURATE SURGICAL CUTS AND IMPROPER FIT OF THE TMJ AND CUSTOM PLATES, ULTIMATELY REQUIRING ABANDONMENT OF THE CUSTOM ORTHOGNATHIC PORTION TO ENSURE STABILITY AND ACCURATE JOINT POSITIONING.

  Patient problems: Insufficient Information; Unspecified Musculoskeletal problem

  MAUDE report 25315530 ↗
• InjuryNov 11, 2025Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A CUSTOM MINI PLATE SNAPPED INSIDE THE PATIENT AND THERE WAS AN INFECTION. THE DOCTOR REMOVED THE PLATE, WASHED OUT THE WOUND, AND RE-PLATED THE OSTEOTOMY USING ANOTHER PLATE.

  Patient problems: Insufficient Information; Pain; Unspecified Infection

  MAUDE report 23522486 ↗
• InjurySep 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Musculoskeletal problem

  MAUDE report 23133686 ↗
• InjurySep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE LEFT FACIAL ID PLATE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125071 ↗
• MalfunctionAug 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PLATE DID NOT FIT AS EXPECTED. SURGEON USED A STOCK PLATE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928806 ↗
• InjuryApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT IT WAS DISCOVERED POST OPERATIVE, THE IMPLANTED MAXILLARY PLATES ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084362 ↗
• MalfunctionApr 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY, THE PLATE DID NOT FIT AS EXPECTED. THE SURGEON CUT THE PLATE TO FIT THE PATIENT. THERE WERE NO REPORTED ADVERSE EVENTS TO THE PATIENT, NO EXTENSIVE SURGERY DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16772420 ↗