MAUDE Adverse Event Report: ALIGN TECHNOLOGY, LTD. ITERO ELEMENT 5D US SYSTEM; CARIES DETECTOR, LASER LIGHT, TRANSMISSION

Model Number	209156
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current user manual for the itero element 5d imaging system contains a contraindication for persons who have been diagnosed with epilepsy.While the treating doctor shared that the patient's eyes were covered with a towel, this may not have provided sufficient coverage from the flashing light of the scanner.The potential root cause of this event is unknown.This event is being filed as an mdr as the patient experienced seizures, resulting in a visit to the emergency room, and the align technology, ltd.Medical device was being used.
Event or Problem Description
The treating doctor reported that the patient was scanned on (b)(6) 2023 and the patient had a seizure.Due to the seizure, the patient went to the emergency room and left the office in an ambulance.It is unknown what medications were prescribed to alleviate the reported symptoms.It is unknown the current condition of the patient, however, the treating doctor assumes the patient is fine.
Additional Manufacturer Narrative
Udi related data quality updates only.Updates were made after reviewing the quality of device identification information submitted previously against data in the gudid.

• Brand Name: ITERO ELEMENT 5D US SYSTEM
• Common Device Name: CARIES DETECTOR, LASER LIGHT, TRANSMISSION
• Manufacturer (Section D): ALIGN TECHNOLOGY, LTD.; 1 yitzhak rabin rd.; petach-tikva, central 49251 10; IS 4925110
• Manufacturer (Section G): ALIGN TECHNOLOGY, LTD.; 1 yitzhak rabin rd.; petach-tikva, central 49251 10; IS 4925110
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 17897108
• Report Number: 3009646999-2023-02943
• Device Sequence Number: 3429930
• Product Code: NTK
• UDI-Device Identifier: 00816063020639
• UDI-Public: (01)00816063020639(11)200826
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 209156
• Device Catalogue Number: 209156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Life Threatening; Other
• Patient Sex: Female