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

Model Number	INVISALIGN GO
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - the root lengths of the teeth may be shortened (root resorption) during orthodontic treatment causing a threat to longevity of the teeth." 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" and "orthodontic treatment (including aligner treatment) may impair the health of the bone and gums which support the teeth and may aggravate the gums".The treating doctor shared that the potential root cause of this event could have been that patient has many heavily restored teeth and a history of tooth fracture, fracture likely due to biting forces and lack of supporting tooth structure (patient's poor pre-existing dental conditions confirmed by align's clinical assessment of available records).No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptoms of required tooth extraction and the need for implant.This event is being filed as an mdr as the patient reported the symptoms of required tooth extraction (serious injury) and the invisalign system aligners were being used.
Event or Problem Description
The patient directly reported the following: the patient reported symptoms of broken lower front tooth, broken crown on lower front tooth, and required tooth extraction and implant.The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient did not report requiring any prescription medications to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners on (b)(6) 2023; however, no progress has been reported to the dental office yet.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: 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: 18610457
• Report Number: 2953749-2024-00078
• Device Sequence Number: 2406056
• Product Code: NXC
• UDI-Device Identifier: 00816063020424
• UDI-Public: (01)00816063020424(10)0149348351(13)230503(91)2037281411N
• Combination Product (Y/N): N
• PMA/510(K) Number: K220287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: INVISALIGN GO
• Device Catalogue Number: 9014
• Device Lot Number: 149348351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 69 YR
• Patient Sex: Female