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

Catalog Number 728-3030

Device Problem Sparking (2595)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had an allergic reaction to spark aligners.Patient symptoms subsided within a few days of not wearing the aligners.

Event Description

Patient had an allergic reaction to spark aligners.

Manufacturer Narrative

The patient is doing fine to date and has fully recovered.

Event Description

Patient took antihistamines for the swelling on lips.The patient has fully recovered.

Event Description

Patient took antihistamines for the swelling on lips.The patient has fully recovered.

Manufacturer Narrative

Corrected date received by manufacturer.

• Brand Name: SPARK ADVANCED
• Type of Device: SPARK ADVANCED ALIGNERS
• Manufacturer (Section D): ORMCO CORPORATION; 1937 w. mission blvd.; pomona, ca
• MDR Report Key: 10393733
• MDR Text Key: 202520417
• Report Number: 2016150-2020-00002
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 728-3030
• Device Lot Number: 114620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR