MAUDE Adverse Event Report: ORMCO CORPORATION SPARK ADVANCED ALIGNERS; SPARK ADVANCED ALGINERS

Model Number	728-3030
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was alleged that a patient had a reaction to the product spark advanced aligners.There was no additional information provided if the patient has fully recovered.A follow up will be done once additional information is given.
Event or Problem Description
The patient has an angioedema diagnosis and has swelling in her mouth when wearing the spark aligners.
Additional Manufacturer Narrative
Multiple attempts were made to contact the complainant by email on (b)(6) 2020, (b)(6) 2020, and (b)(6) 2020 in order to obtain further information on the well being of the patient; however, the complainant has remained unresponsive.No further information has been received to suggest that a serious injury was associated with this incident.

• Brand Name: SPARK ADVANCED ALIGNERS
• Common Device Name: SPARK ADVANCED ALGINERS
• Manufacturer (Section D): ORMCO CORPORATION; 1937 w. mission blvd; pomona, ca
• MDR Report Key: 10083283
• Report Number: 2016150-2020-00001
• Device Sequence Number: 11609132
• Product Code: NXC
• UDI-Device Identifier: 00889989083460
• UDI-Public: 00889989083460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: No Information
• Device Model Number: 728-3030
• Device Catalogue Number: 728-3030
• Device Lot Number: 113997
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other