MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC INVISALIGN SYSTEM; SEQUENTIAL ALIGNERS

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tooth Fracture (2428)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

This event is being filed as an mdr as the patient lost a tooth and an align product may have contributed to the event.

Event Description

The patient reported the symptoms of pain due to the attachments and extraction of tooth #31 (lower right 2nd molar) after it cracked.The patient did not report requiring any medical intervention due to the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The treatment has not been discontinued as the patient is still wearing the aligners and is currently getting better.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: nestor vazquez ; 2820 orchard parkway; san jose, CA 95134 ; 4084701480
• MDR Report Key: 11275761
• MDR Text Key: 230243905
• Report Number: 2953749-2021-00105
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8820
• Device Lot Number: 37190935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2018
• 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: 63 YR