MAUDE Adverse Event Report: SMILE DIRECT CLUB/ ALIGN TECHNOLOGY, INC. RETAINERS; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Sensitivity of Teeth (2427); Tooth Fracture (2428)

Event Date 08/15/2019

Event Type  Injury  

Event Description

Broke and fractures bones in my jaw! i started noticing almost at the end of my retainer treatment, that was personalized and set to a fixed schedule from smile direct that one of my teeth was wiggly and painful.I immediately contacted smile direct, i was then scheduled an appointment to do a 3d scan of only the shifting of my teeth in (b)(6).I arrived to a smile direct business office without seeing or speaking with a dentist only two smile direct employees to do a 3d scan of my teeth.The 3d scan only consisted of a scan of my teeth, not my bones even though i explained my issue when i first contacted smile direct and when meeting with the two smile direct employees.They both told me to "continue my weeks as is" and your teeth may wiggle just a little from the shifting.They said the dentist would call me after she reviewed my 3d scan.I never received a call nor a follow up from smile direct.The pain consisted and became unbearable therefore i scheduled an appointment to see my dentist in (b)(6).The dentist took photos, x- rays, looked at my teeth, and then referred me to an orthodontist.I went to the orthodontist and they also took x-rays and noticed that i had multiple fractures and a broken bone in the middle portion of my lower jaw.I explained to the orthodontist my personalized shifting schedule from smile direct.The orthodontist explained that the reason for my broken bone and fractures in my teeth and jaw is because smile direct had me shifting every two weeks.The orthodontist explained that safe shifting of teeth takes 6 weeks to heal from every shift.The orthodontist insisted that the shifting was too frequent and very dangerous.The orthodontist put a fixed retainer on the bottom of my teeth where the fractures and broken bone is.The orthodontist explained the fixed retainer may help heal the fractures and broken bone.Well it has been about 12 months and my bone is still broken.I will most likely end up with expensive dentures that i can't afford.Thank you smile direct.Fda safety report id # (b)(4).

• Brand Name: RETAINERS
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): SMILE DIRECT CLUB/ ALIGN TECHNOLOGY, INC.
• MDR Report Key: 10733225
• MDR Text Key: 213434218
• Report Number: MW5097435
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• 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: 10/21/2020

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 49