MAUDE Adverse Event Report: SMYLIO FXTETRA BRIGHT RETAINER; DENTAL RETAINER

Lot Number SMY-009

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

Patient Problem Tooth Fracture (2428)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned and analyzed.No issues were found with the device or in the manufacturing process/records for the device.Trend and risk analysis reports were pulled, reviewed and discussed with professional medical personnel (dentists) to assess the case.The conclusion was that the patient's previous dental restoration work was in poor shape.This dental work was not associated or related to the product at all.This poor dental work was determined to be the root cause of the event.The device performed as intended.

Event Description

Patient reported that a small chip of her tooth came out when removing the dental retainer at night.She returned the product for evaluation.The customer service team advised her to seek a dental professional for help with her tooth.The patient then stop responding to our emails and calls.We have tried 3 or more times to contact her to so we can understand any resolution to this case.We have no responses at this point.

• Brand Name: FXTETRA BRIGHT RETAINER
• Type of Device: DENTAL RETAINER
• Manufacturer (Section D): SMYLIO; 48890 milmont drive; fremont CA 94538
• Manufacturer Contact: jennifer day ; 48890 milmont drive; fremont, CA 94538 ; 3148091818
• MDR Report Key: 11838786
• MDR Text Key: 251114094
• Report Number: 3015143007-2021-00001
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2021
• Device Lot Number: SMY-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR