MAUDE Adverse Event Report: SDS DE MEXICO SPARK ADVANCED

Catalog Number 728-3032

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Sensitivity of Teeth (2427)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Patient claims passive aligners pressure on gums and caused gingival recession on tooth #25.

Manufacturer Narrative

Treatment start (b)(6) 2021, first refinement start (b)(6) 2022 with gingival tissue recession similar to what present at the start of the treatment/ refinement #2 start (b)(6) 2022 a recession on tooth #25 had increase.Based on doctor's pre-treatment photos, patient had areas of recession.Gingival recession was noted on initial exams letters for the patient and was refer to a general dentist to recommend the periodontist she preferred to use.Per report form periodontist, grafting is advised and scheduled for some time in (b)(6) 2023.Patient is not fully recovered, the tissue appears to be stable as of the last visit but gum recession would need to be treated as per the periodontist's recommendation.

• Brand Name: SPARK ADVANCED
• Type of Device: SPARK ADVANCED
• Manufacturer (Section D): SDS DE MEXICO; cto. sur 31, nelson; mexicali, mexico 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; cto. sur 31, nelson; mexicali, mexico 21395 ; MX 21395
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 15640194
• MDR Text Key: 302092375
• Report Number: 2016150-2022-00004
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 728-3032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Female