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

Model Number	VIVERA RETAINERS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tooth Loss (4831)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional 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".The treating doctor shared that the potential root cause of this event could have been that the orthodontic treatment may have exacerbated the patient's pre-existing conditions.This event is being filed as an mdr as the treating doctor reported that the patient had the symptom of tooth extraction (serious injury), and the vivera retainers were being used.
Event or Problem Description
The patient directly reported to align the following symptoms: tooth protruding from gum, tooth infection, and tooth extraction (3 permanent teeth) with a bridge installed.The treating doctor reported that the patient had the following symptoms: severe distal bone loss and mobility on tooth #23, leading to extraction of tooth #23.The treating doctor reported that the patient required the following medical intervention to alleviate the reported symptoms: visiting a periodontist, extraction of tooth #23, and a bridge installed from tooth #22-24; and the patient was prescribed amoxicillin.The treating doctor reported that the patient was doing fine, from the last office visit a few years ago.

• Brand Name: VIVERA RETAINERS
• Common Device Name: 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: 19644430
• Report Number: 2953749-2024-01650
• Device Sequence Number: 17789044
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0059131146(13)191107(91)0695975001R
• Combination Product (Y/N): N
• 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): 07/01/2024

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: VIVERA RETAINERS
• Device Catalogue Number: 8579
• Device Lot Number: 59131146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2019
• 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: 60 YR
• Patient Sex: Female