MAUDE Adverse Event Report: BYTE / STRAIGHT SMILE, LLC INVISALINERS; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 09/02/2020

Event Type  Injury  

Event Description

I was using byte aligners, had not had them in 3 weeks and started experiencing problems with pain in my jaw had an infection start in my dental implant which had to be removed contacted byte, they refused to refund my money after i offered to return unused aligners.Fda safety report id# (b)(4).

• Brand Name: INVISALINERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): BYTE / STRAIGHT SMILE, LLC
• MDR Report Key: 10945717
• MDR Text Key: 220003784
• Report Number: MW5098199
• Device Sequence Number: 1
• Product Code: NXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 77