MAUDE Adverse Event Report: AMERICAN ORTHODONTICS PALATAL ARCH

Model Number	852-543L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device returned to american orthodontics for evaluation.Product appeared to be intact; it was not broken or fractured.Appeared that the product deformed/bent by the user.Cannot confirm the product was made by american orthodontics but cannot rule out this possibility.No additional detail was provided by the respondents regarding the incident, despite multiple attempts by american orthodontics.It remains unclear how the product was used.
Event or Problem Description
Product was swallowed by the patient and had to be surgically removed.

• Brand Name: PALATAL ARCH
• Common Device Name: PALATAL ARCH
• Manufacturer (Section D): AMERICAN ORTHODONTICS; 3524 washington avenue; sheboygan WI 53081
• Manufacturer (Section G): AMERICAN ORTHODONTICS; 3524 washington avenue; sheboygan WI 53081
• Manufacturer Contact: bruce deemer ; 3524 washington avenue; sheboygan, WI 53081
• MDR Report Key: 18363745
• Report Number: 2126683-2023-00001
• Device Sequence Number: 20836790
• Product Code: DYJ
• UDI-Device Identifier: 00190746133411
• UDI-Public: (01)00190746133411
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 852-543L
• Device Catalogue Number: 852-543L
• Device Lot Number: Q14767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown