MAUDE Adverse Event Report: SDS DE MEXICO SPARK 20 - DUAL ARCH

Catalog Number	728-3020
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient had an allergic reaction to the first set of aligners.Symptoms patient experienced were not provided.Based on doctor's professional opinion allergic reaction can be a serious injury for possible anaphylaxis.Patient did not go to the hospital and was not referral to another type of doctor.Patient is fully recovered.

• Brand Name: SPARK 20 - DUAL ARCH
• Common Device Name: SPARK 20 - DUAL ARCH
• Manufacturer (Section D): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821
• MDR Report Key: 18095481
• Report Number: 2016150-2023-00007
• Device Sequence Number: 6754573
• Product Code: NXC
• UDI-Device Identifier: 00889989083453
• UDI-Public: 00889989083453
• 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): 11/08/2023

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: 728-3020
• Device Lot Number: 1488803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male