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

Catalog Number 728-3030

Device Problem Sparking (2595)

Patient Problems Irritation (1941); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The patient discontinued wearing spark advanced aligner and the gum swelling and irritation was resolved.Currently patient has not decided if they will continue with the treatment of spark.A follow up will be done once additional information is given.

Event Description

It was alleged that a patient had gum swelling and irritation after wearing spark advanced aligner.

Manufacturer Narrative

Corrected date received by manufacturer.

Event Description

It was alleged that a patient had gum swelling and irritation after wearing spark advanced aligner.

• Brand Name: SPARK ADVANCED
• Type of Device: SPARK ADVANCED ALIGNERS
• Manufacturer (Section D): ORMCO CORPORATION; 1937 w. mission blvd.; pomona CA 91766
• MDR Report Key: 10702191
• MDR Text Key: 212064930
• Report Number: 2016150-2020-00004
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: 109857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other