MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. VIVERA RETAINER; MAINTAINER, SPACE PREFORMED, OTHODONTIC

Model Number VIVERA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tooth Fracture (2428)

Event Date 01/01/2022

Event Type  Injury  

Event Description

The patient reported symptoms of pain in right side and fracture and removal of tooth #5 (due to worsening with retainer pressure).The patient reported requiring visiting an endodontist to alleviate the reported symptoms.The patient reported being prescribed ibuprofen to alleviate the reported symptoms.The patient is continuing the use of the retainers, but the condition has not improved.

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the vivera retainer caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported tooth loss (permanent impairment to body structure) and the vivera retainer was being used.

• Brand Name: VIVERA RETAINER
• Type of Device: MAINTAINER, SPACE PREFORMED, OTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134 ; 4087891588
• MDR Report Key: 13467417
• MDR Text Key: 285152572
• Report Number: 2953749-2022-00040
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINER
• Device Catalogue Number: 7883
• Device Lot Number: 204162937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2021
• 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): Disability
• Patient Age: 53 YR
• Patient Sex: Female