MAUDE Adverse Event Report: ORAMETRIX INC. SURESMILE ALIGNER; ALIGNER, SEQUENTIAL

Catalog Number 856379007023

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

Patient appears to be having an allergic reaction to suresmile aligners (tray 12).Patient states, swelling of soft palate, gingiva, uvula, complains of issues with swallowing and breathing.Patient has since discontinued use of the aligners.

Manufacturer Narrative

The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: SURESMILE ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ORAMETRIX INC.; 2350 campbell creek blvd.; suite 400; richardson TX 75082
• MDR Report Key: 12064615
• MDR Text Key: 258320966
• Report Number: 1649995-2021-00001
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• PMA/PMN Number: K171860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 856379007023
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other