MAUDE Adverse Event Report: ORMCO CORPORATION SPARK ADVANCED

Catalog Number	728-3030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient developed a severe medical complication from an allergic response to the aligners.Patient first reported sensation of tingling and bitterness taste in her tongue after 2 days of wearing aligners.Doctor suggested her to wear the aligners for a full week since there is an adjustment period to aligners.After 1 week of wearing them, patient reported that her symptoms had not improved.But worsened.Patient looked for medical attention with a familiar medicine doctor for this reaction.The diagnosis was edema of the epiglottis from allergic reaction.It was prescribed zyrtec and the patient is fully recovered.
Additional Manufacturer Narrative
It was reported a patient developed a severe medical complication from an allergic response to the aligners.Patient first reported sensation of tingling and bitterness taste in her tongue after 2 days of wearing aligners.Doctor suggested her to wear the aligners for a full week since there is an adjustment period to aligners.After 1 week of wearing them, patient reported that her symptoms had not improved but worsened.Patient looked for medical attention with a familiar medicine doctor for this reaction.The diagnosis was edema of the epiglottis from allergic reaction.It was prescribed zyrtec and the patient is fully recovered.

• Brand Name: SPARK ADVANCED
• Common Device Name: SPARK ADVANCED
• Manufacturer (Section D): ORMCO CORPORATION; 1937 west mission blvd; pomona CA 91766
• Manufacturer (Section G): ORMCO; 1937 west mission blvd; pomona CA 91766
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 17844450
• Report Number: 2016150-2023-00004
• Device Sequence Number: 17953821
• Product Code: NXC
• UDI-Device Identifier: 00889989083460
• UDI-Public: 00889989083460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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
• Device Catalogue Number: 728-3030
• Device Lot Number: 1459798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic