MAUDE Adverse Event Report: ORMCO CORPORATION SPARK ADVANCED

Catalog Number 728-3030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had reported lips, gums, and cheeks were swollen.The first stage of inserting spark advanced on (b)(6) and on monday (b)(6) the patient reported the swelling and stopped treatment.Dr.Thompson thinks it may be an allergic reaction.No further information has been provided.Upon further information and update will be submitted.

Event Description

It was alleged that a patient reported lips, gums and cheeks were swollen.

• Brand Name: SPARK ADVANCED
• Type of Device: SPARK ADVANCED
• Manufacturer (Section D): ORMCO CORPORATION; 200 s. kramer blvd, buidling e; brea CA 92821
• Manufacturer (Section G): ORMCO CORPORATION; 1937 w. mission blvd.; pomona CA 91766
• Manufacturer Contact: procoro herrera ; 200 s. kramer blvd, buidling e; brea, CA 92821 ; 7148174396
• MDR Report Key: 11962337
• MDR Text Key: 255056754
• Report Number: 2016150-2021-00004
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 298679
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1