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

Model Number INVISALIGN RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tooth Fracture (2428)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients -a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost" and "health of the bone and gums which support the teeth may be impaired or aggravated." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign retainers caused the reported symptom of tooth extraction.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign retainers were being used.This event was reported by the patient (initial reporter).

Event Description

The patient reported that bone was infected due to cracked root, and ended up needing a bone graft, extraction and implant (tooth # unspecified).It is unknown if the patient required any medical intervention to alleviate the reported symptoms.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is still wearing the retainers.

• Brand Name: INVISALIGN RETAINER; VIVERA RETAINER
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• 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: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 17224575
• MDR Text Key: 318083616
• Report Number: 2953749-2023-02074
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020660
• UDI-Public: (01)00816063020660(10)0055583718(13)190827(91)0602069201R
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN RETAINER
• Device Catalogue Number: 9028
• Device Lot Number: 55583718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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: 45 YR
• Patient Sex: Female