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

Model Number	INVISALIGN SYSTEM - MODERATE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - the health of the bone and gums which support the teeth may be impaired or aggravated" and "the length of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth" and "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".The treating doctor shared that the potential root cause could have been the force of large attachments, angle of aligner removal, and query of recent extraction of tooth 4.2.Per align's clinical review of the event, tooth 4.2 was extracted as part of the treatment plan.After the extraction of tooth 4.2, the patient removed the aligners and suffered a physical trauma on tooth 4.3, which resulted in an avulsion (post-extraction of adjacent tooth 4.2).The tooth 4.3 required medical intervention to prevent tooth loss (patient required splint for 3 weeks).This event is being filed as an mdr as the treating doctor reported that the patient had symptom of symptom of tooth avulsion of 4.3 and splint required to prevent tooth loss (serious injury) and the invisalign system aligners were being used.
Event or Problem Description
The treating doctor reported that the patient had symptom of avulsion of whole tooth 4.3, when removing the patient's first aligner post extraction.The treating doctor reported that the patient required the following medical intervention to alleviate the reported symptom of tooth avulsion of 4.3: patient required a splint for 3 weeks.It is unknown if medications were prescribed or used to alleviate the patient's reported symptom.The treating doctor reported that the patient is continuing the use of the aligners and is currently getting better.

• 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: 19028914
• Report Number: 2953749-2024-00904
• Device Sequence Number: 8187819
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0176483526(13)240220(91)2323059901N
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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 SYSTEM - MODERATE
• Device Catalogue Number: 9001
• Device Lot Number: 176483526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female