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

Catalog Number 856379007023

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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

It was reported that a patient experienced an allergic reaction to the use of suresmile aligners.The patient has stopped treatment and will not continue.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• 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: 10837118
• MDR Text Key: 216179732
• Report Number: 1649995-2020-00003
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 856379007023
• Device Lot Number: W6G6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other