PALATAL ARCH
Received Dec 20, 2023 · Event occurred May 30, 2023
Report 2126683-2023-00001 · MDR key 18363745
Device
Generic name
Palatal Arch
Manufacturer
American OrthodonticsModel number
852-543LCatalog number
852-543L
Lot number
Q14767
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
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.
Description of Event or Problem
PRODUCT WAS SWALLOWED BY THE PATIENT AND HAD TO BE SURGICALLY REMOVED.