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

Model Number	INVISALIGN EXPRESS 10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994)
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 "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".Align's clinical review of available records (initial xray) showed evidence of pre-existing generalized bone loss and panoramic x-ray showed what appears to be pre-existing periapical lesions on upper anterior teeth.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the required medical intervention to prevent permanent damage (tooth loss), and therefore, this event is being filed as an mdr per 21 cfr 803.There is no conclusive evidence to confirm the date of the required medical intervention.The patient's reported symptoms began in (b)(6) 2021, and the patient was diagnosed and recommended for oral surgery in (b)(6) 2022.
Event or Problem Description
The treating doctor reported that the patient had symptoms of infection, tooth mobility, pain and trauma on periodontal ligament.The patient required visiting a periodontist and an orthodontist who referred patient to an endodontist and oral surgeon for further treatment, and prescribed oral surgery.The patient was prescribed with the following medication: pain meds, periodontal splints for stabilization, oral surgery for root resorption and facial trigger point injections.

• 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 ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20413791
• Report Number: 2953749-2024-02793
• Device Sequence Number: 8401102
• Product Code: NXC
• UDI-Device Identifier: 00816063020042
• UDI-Public: (01)00816063020042(10)0097524033(13)210826(91)1338677410N
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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 EXPRESS 10
• Device Catalogue Number: 8512
• Device Lot Number: 97524033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2021
• 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: 44 YR
• Patient Sex: Female