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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tooth Fracture (2428)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "precautions - existing dental restorations (e.G., crowns or bridges) may become dislodged and require re-cementation or, in some instances, replacement" and "a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the 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".Align's clinical analysis confirm from initial records that tooth #15 was a bridge and tooth #30 a metallic crown, both had rct, moderate bone loss, and compromised prognosis.Tooth #7 had mild bone loss, recessions were not present, and it had tooth decay on the palatal surface; however, there were no signs of a poor prognosis prior to the use of aligner treatment.The treating doctor shared that the potential root cause of tooth #7 being extracted is the fracture, which was reported to be from the pre-existing decay, and occurred while the patient was taking out aligner #14.The treating doctor shared that the extraction was an unexpected tooth loss, not part of the original treatment plan, and shared that the patient was not compliant with the treatment.This event is being filed as an mdr as the patient reported symptom of tooth extraction (serious injury) and the invisalign system aligners were being used.

Event Description

The patient directly reported (on (b)(6) 2024) the following symptoms: in 2022, the patient had symptoms of extreme pain in the teeth, tooth mobility, tooth fracture in #31 and #15, cuts in the patient's cheeks and tongue due to the broken teeth.In 2021, the patient had symptoms of fracture in tooth #7 that required extraction.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 continuing to use the aligners and the patient's current condition is unknown.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• 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: 18954076
• MDR Text Key: 338304166
• Report Number: 2953749-2024-00736
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0053974368(13)190723(91)0932547614N
• Combination Product (y/n): N
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 9000
• Device Lot Number: 53974368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female